Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359431
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-14
Brief Title:
A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening
Sponsor:
GICMED
Organization:
GICMED
Study Overview
Official Title:
A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
Objective The main objective of this study is to verify the level of comfort for patients and the degree of cervical visibility for health providers using a novel smart speculum compared to the standard speculum In addition establish the feasibility of using this novel smart speculum device with telemedicine for cervical cancer screening in a low-resource setting using VIA compared to the standard of care
Study sites The study will be carried out in six health facilities in the centre region of Cameroon
Study Period The study is expected to take 11 months 4 months for protocol development and approval 4 months for the training and implementation phase with data collection 3 months for data analysis reporting writing and dissemination
Study design The study will be a multicentre randomised control single blind trial Patient participation will be a single study visit Eligible subjects consenting to participate will act as their own controls and will receive speculum examination and cervical cancer screening with both the novel speculum and a traditional speculum The order of usage of the specula will be randomised and the women will be blinded on knowing which speculum is being used at a particular time Level of patient comfort will be evaluated using a visual analogue scale percentage visualisation of the cervix will be determined following insertion of each of the specula and results of cervical cancer screening following VIA screening method will be compared between the standard of care procedure to that using the novel smart speculum associated to telemedicine
Patient population All women between the ages of 21 years and 49 years who come in for consultation
Enrolment size 81 women will be enrolled in the study Study procedure A speculum examination will be done on the day of consultation Level of patient comfort determined using a visual analogue scale and proportion of the cervix visualised would be recorded into questionnaires Cervical cancer screening through VIA will be performed with results confirmed on site by the clinician using the standard speculum while two other clinicians for each case will do a remote diagnosis after reviewing images captured through the novel speculum device and forwarded to them through telemedicine The remote clinicians will be blinded on the diagnosis proposed by the clinician on site
Primary endpoints The proportion of clinicians with easy visualisation of the cervix with the 2 specula level of patient comfort with the novel smart speculum compared to the Standard of care speculum traditional speculum reliability of the speculum in carrying out cervical cancer screening using telemedicine
Ethical considerations The protocol will be submitted for the approval of the National Human Health Research Committee Written informed consent will be sought for all participants before enrolment into the study
Study sites The study will be carried out in six health facilities in the centre region of Cameroon
Study Period The study is expected to take 11 months 4 months for protocol development and approval 4 months for the training and implementation phase with data collection 3 months for data analysis reporting writing and dissemination
Study design The study will be a multicentre randomised control single blind trial Patient participation will be a single study visit Eligible subjects consenting to participate will act as their own controls and will receive speculum examination and cervical cancer screening with both the novel speculum and a traditional speculum The order of usage of the specula will be randomised and the women will be blinded on knowing which speculum is being used at a particular time Level of patient comfort will be evaluated using a visual analogue scale percentage visualisation of the cervix will be determined following insertion of each of the specula and results of cervical cancer screening following VIA screening method will be compared between the standard of care procedure to that using the novel smart speculum associated to telemedicine
Patient population All women between the ages of 21 years and 49 years who come in for consultation
Enrolment size 81 women will be enrolled in the study Study procedure A speculum examination will be done on the day of consultation Level of patient comfort determined using a visual analogue scale and proportion of the cervix visualised would be recorded into questionnaires Cervical cancer screening through VIA will be performed with results confirmed on site by the clinician using the standard speculum while two other clinicians for each case will do a remote diagnosis after reviewing images captured through the novel speculum device and forwarded to them through telemedicine The remote clinicians will be blinded on the diagnosis proposed by the clinician on site
Primary endpoints The proportion of clinicians with easy visualisation of the cervix with the 2 specula level of patient comfort with the novel smart speculum compared to the Standard of care speculum traditional speculum reliability of the speculum in carrying out cervical cancer screening using telemedicine
Ethical considerations The protocol will be submitted for the approval of the National Human Health Research Committee Written informed consent will be sought for all participants before enrolment into the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None