Ignite Creation Date:
2024-05-06 @ 8:35 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02773420
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2016-05-12
Brief Title:
HET Bipolar System Validation of Outpatient Hemorrhoid Treatment
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
HET Bipolar System Validation of a New Minimally Invasive Outpatient Treatment for Symptomatic Hemorrhoids
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HET
Brief Summary:
Purpose The current study aims to evaluate the safety and effectiveness of the HET Bipolar System Medtronic Boulder CO for the treatment of grade I-II hemorrhoids in a prospective pilot study This device was evaluated retrospectively in a limited cohort of 23 patients previously
Methods Patients seen at a colorectal clinic in a single institution with grade I-II hemorrhoids are offered to participate in a prospective pilot trial The HET device is a modified anoscope equipped with LED lighting a tissue clamping mechanism and a bipolar energy source used to treat multiple hemorrhoidal columns in one sitting Three columns of hemorrhoids are treated with 2 heat energy applications per column The primary outcome is the treatment effect on hemorrhoid symptoms of bleeding pain prolapse itching and soiling This is measured with a patient completed questionnaire documenting each symptoms frequency from 0 to 3 ie 0 is 1xmonth 3 is daily before therapy and at 3 weeks and 6 month follow-up Post-treatment pain scores were recorded using the visual analog scale VAS
Methods Patients seen at a colorectal clinic in a single institution with grade I-II hemorrhoids are offered to participate in a prospective pilot trial The HET device is a modified anoscope equipped with LED lighting a tissue clamping mechanism and a bipolar energy source used to treat multiple hemorrhoidal columns in one sitting Three columns of hemorrhoids are treated with 2 heat energy applications per column The primary outcome is the treatment effect on hemorrhoid symptoms of bleeding pain prolapse itching and soiling This is measured with a patient completed questionnaire documenting each symptoms frequency from 0 to 3 ie 0 is 1xmonth 3 is daily before therapy and at 3 weeks and 6 month follow-up Post-treatment pain scores were recorded using the visual analog scale VAS
Detailed Description:
HET Bipolar System Validation of Outpatient Hemorrhoid Treatment
Introduction This study will evaluate the effectiveness of treatment of Grade I-II hemorrhoids with the novel HET Bipolar System Medtronic Boulder Co This device is a modified anoscope equipped with LED lighting tissue clamping mechanism and bipolar energy device It is inserted in the anus under direct vision targeting the tissue proximal to the hemorrhoid which is placed within the treatment window and clamped The bipolar energy device is activated to ligate the feeding hemorrhoidal vessels essentially disrupting the blood supply to the hemorrhoid The only published evaluation of this device to date is a retrospective analysis of the safety and efficacy of the device in 23 patients 1
There is no prospective study of this device and its effectiveness in the literature The investigators aim to evaluate the efficacy of this device defined as decrease in symptoms andor recurrence of Grade I-II hemorrhoids through a prospective study consisting of 30 patients Other non invasive means of treating hemorrhoids range from sclerotherapy to rubber band ligation which often requires multiple treatments and can cause some discomfort The investigators aim to study HET Bipolar treatment of hemorrhoids to offer another validated minimally invasive option for the treatment of symptomatic hemorrhoids in the outpatient setting
Research Design and Method The investigators will enroll a total of 30 subjects Participating patients18 years of age and older will be undergoing treatment with the HET bipolar system for symptomatic Grade I and II hemorrhoids Please note that the HET bipolar system is used as part of standard of care and participants will receive the treatment regardless of this research The subjects will be identified and recruited by University of Illinois at Chicago Department of Colorectal Surgery faculty via clinic appointments in the Outpatient Care Center 1801 W Taylor St Suite 3F Chicago Il 60612 Informed consent will be provided at the clinic in regards to participation in the study Refusal to participate will not influence treatment options presented or deemed necessary for the subjects condition A pretreatment hemorrhoid symptom questionnaire will be completed by each patient In developing our questionnaire the investigators examined the only validated hemorrhoidal symptom questionnaire in the literature the Sodergren Score 2 and also various others 3 The Sodergren score offers a theoretical basis however the investigators chose to develop a questionnaire secondary to the need for inclusion of bleeding symptoms of hemorrhoids While subjects are undergoing treatment the investigators will record timing of treatment number of hemorrhoids treated and energy application timing Immediately after the treatment the patients will describe how painful the procedure was using the Visual Analog Scale VAS The questionnaire will take 5-10 minutes to complete Patients will be seen for follow up outpatient clinic visits at 2-3 weeks and at 8-12 weeks post procedure At follow up the patients will be given a post-treatment questionnaire regarding symptoms of hemorrhoids this is the same questionnaire as the pre-treatment questionnaire The questionnaire assigns each of the five cardinal symptoms of hemorrhoids with a number from 0 to 3 with 3 being the most severe symptom After tallying the five symptom scores a total from 0 no symptoms to 15 severe symptoms will be assigned to each patients overall symptoms In addition patients will be given a journal to record their daily pain for 14 consecutive days day 21 and day 56 using the Visual Analog Scale VAS This is to more accurately record pain as the questionnaire does not include a VAS score component Patients who are unable to come for follow up visits will be interviewed over the phone by one of the investigators and the relevant data ie the questionnaire and pain score will be obtained during this phone conversation For patients following up over the phone a phone script will be created in addition to the questionnaire The total number of visitsencounters is 3 and will take place during regular clinic visit appointments The difference between pre treatment and post treatment scores will be representative of the treatment effect
Statistical Section
Descriptive statistics will be used to describing the distribution of data The Wilcoxon signed rank test will be used to examine the pre- and post- treatment symptom score difference Paired two-sample t-test and McNemars test will also be used to examine the pre- and post-treatment difference for other variables of interests
Sample size justification
Since the Wilcoxon signed rank test will be used to test the significant difference between pre- and post- treatment scores the power calculation is based on the Wilcoxon signed rank test At 80 power level assuming correlation 02 between pre- and post- treatment scores the sample size of 18 ensure minimum detectable difference in symptom score between pre- and post-treatment scores of 3 Thus our sample size of 30 is appropriate
Example At 80 power level assuming correlation 02 between pre- and post- treatment scores the sample size of 18 ensure minimum detectable difference in symptom score between pre- and post-treatment scores of 3
Expected ResultsConclusions The investigators anticipate a significant decrease of hemorrhoidal symptoms defined in this study as pain pruritis prolapse soiling and bleeding with the HET bipolar system providing a validated outpatient minimally invasive treatment option for symptomatic hemorrhoids
BenefitsRisks There is no direct benefit to the subjects of this study The main risk of this research is loss of confidentiality of information The patient may experience mild anxiety or discomfort in providing information about their health and well-being Records will be stored in an electronic data file on a password protected computer in a locked office Master key will be kept in a separate file accessible only by the primary investigator
Informed Consent
Informed consent will be provided at the clinic in regards to participation in the study Refusal to participate will not influence treatment options presented or deemed necessary for the subjects condition Consent will be obtained by the primary investigator andor research fellows who have experience and training in the explanation of the procedure potential risks and benefits The informed consent document will be stored in the subjects electronic medical record If non-English speaking subjects are encountered the informed consent will be translated by interpretation in the language of the subject
Data and Safety Monitoring Plan
This study poses minimal risk the main risk being mild anxiety or loss of confidentiality of information If problems arise they will be handled according to Institutional Review Board protocol
Data Collection and Management Procedures
Data procurement will be done electronically and incorporated in password protected encrypted server in a locked office The master key will be kept in a separate file accessible only by the primary investigator
Reporting Unanticipated Problems
If any unanticipated problems arise they will be reported to University of Illinois at Chicagos Insitutional Review Board per defined protocol
Introduction This study will evaluate the effectiveness of treatment of Grade I-II hemorrhoids with the novel HET Bipolar System Medtronic Boulder Co This device is a modified anoscope equipped with LED lighting tissue clamping mechanism and bipolar energy device It is inserted in the anus under direct vision targeting the tissue proximal to the hemorrhoid which is placed within the treatment window and clamped The bipolar energy device is activated to ligate the feeding hemorrhoidal vessels essentially disrupting the blood supply to the hemorrhoid The only published evaluation of this device to date is a retrospective analysis of the safety and efficacy of the device in 23 patients 1
There is no prospective study of this device and its effectiveness in the literature The investigators aim to evaluate the efficacy of this device defined as decrease in symptoms andor recurrence of Grade I-II hemorrhoids through a prospective study consisting of 30 patients Other non invasive means of treating hemorrhoids range from sclerotherapy to rubber band ligation which often requires multiple treatments and can cause some discomfort The investigators aim to study HET Bipolar treatment of hemorrhoids to offer another validated minimally invasive option for the treatment of symptomatic hemorrhoids in the outpatient setting
Research Design and Method The investigators will enroll a total of 30 subjects Participating patients18 years of age and older will be undergoing treatment with the HET bipolar system for symptomatic Grade I and II hemorrhoids Please note that the HET bipolar system is used as part of standard of care and participants will receive the treatment regardless of this research The subjects will be identified and recruited by University of Illinois at Chicago Department of Colorectal Surgery faculty via clinic appointments in the Outpatient Care Center 1801 W Taylor St Suite 3F Chicago Il 60612 Informed consent will be provided at the clinic in regards to participation in the study Refusal to participate will not influence treatment options presented or deemed necessary for the subjects condition A pretreatment hemorrhoid symptom questionnaire will be completed by each patient In developing our questionnaire the investigators examined the only validated hemorrhoidal symptom questionnaire in the literature the Sodergren Score 2 and also various others 3 The Sodergren score offers a theoretical basis however the investigators chose to develop a questionnaire secondary to the need for inclusion of bleeding symptoms of hemorrhoids While subjects are undergoing treatment the investigators will record timing of treatment number of hemorrhoids treated and energy application timing Immediately after the treatment the patients will describe how painful the procedure was using the Visual Analog Scale VAS The questionnaire will take 5-10 minutes to complete Patients will be seen for follow up outpatient clinic visits at 2-3 weeks and at 8-12 weeks post procedure At follow up the patients will be given a post-treatment questionnaire regarding symptoms of hemorrhoids this is the same questionnaire as the pre-treatment questionnaire The questionnaire assigns each of the five cardinal symptoms of hemorrhoids with a number from 0 to 3 with 3 being the most severe symptom After tallying the five symptom scores a total from 0 no symptoms to 15 severe symptoms will be assigned to each patients overall symptoms In addition patients will be given a journal to record their daily pain for 14 consecutive days day 21 and day 56 using the Visual Analog Scale VAS This is to more accurately record pain as the questionnaire does not include a VAS score component Patients who are unable to come for follow up visits will be interviewed over the phone by one of the investigators and the relevant data ie the questionnaire and pain score will be obtained during this phone conversation For patients following up over the phone a phone script will be created in addition to the questionnaire The total number of visitsencounters is 3 and will take place during regular clinic visit appointments The difference between pre treatment and post treatment scores will be representative of the treatment effect
Statistical Section
Descriptive statistics will be used to describing the distribution of data The Wilcoxon signed rank test will be used to examine the pre- and post- treatment symptom score difference Paired two-sample t-test and McNemars test will also be used to examine the pre- and post-treatment difference for other variables of interests
Sample size justification
Since the Wilcoxon signed rank test will be used to test the significant difference between pre- and post- treatment scores the power calculation is based on the Wilcoxon signed rank test At 80 power level assuming correlation 02 between pre- and post- treatment scores the sample size of 18 ensure minimum detectable difference in symptom score between pre- and post-treatment scores of 3 Thus our sample size of 30 is appropriate
Example At 80 power level assuming correlation 02 between pre- and post- treatment scores the sample size of 18 ensure minimum detectable difference in symptom score between pre- and post-treatment scores of 3
Expected ResultsConclusions The investigators anticipate a significant decrease of hemorrhoidal symptoms defined in this study as pain pruritis prolapse soiling and bleeding with the HET bipolar system providing a validated outpatient minimally invasive treatment option for symptomatic hemorrhoids
BenefitsRisks There is no direct benefit to the subjects of this study The main risk of this research is loss of confidentiality of information The patient may experience mild anxiety or discomfort in providing information about their health and well-being Records will be stored in an electronic data file on a password protected computer in a locked office Master key will be kept in a separate file accessible only by the primary investigator
Informed Consent
Informed consent will be provided at the clinic in regards to participation in the study Refusal to participate will not influence treatment options presented or deemed necessary for the subjects condition Consent will be obtained by the primary investigator andor research fellows who have experience and training in the explanation of the procedure potential risks and benefits The informed consent document will be stored in the subjects electronic medical record If non-English speaking subjects are encountered the informed consent will be translated by interpretation in the language of the subject
Data and Safety Monitoring Plan
This study poses minimal risk the main risk being mild anxiety or loss of confidentiality of information If problems arise they will be handled according to Institutional Review Board protocol
Data Collection and Management Procedures
Data procurement will be done electronically and incorporated in password protected encrypted server in a locked office The master key will be kept in a separate file accessible only by the primary investigator
Reporting Unanticipated Problems
If any unanticipated problems arise they will be reported to University of Illinois at Chicagos Insitutional Review Board per defined protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISR-2015-10644 | OTHER_GRANT | Medtronic | None |