Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395675
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-29
Brief Title:
Clinical Evaluation of the ID NOW CTNG Test
Sponsor:
Abbott Rapid Dx
Organization:
Abbott Rapid Dx
Study Overview
Official Title:
Clinical Evaluation of the ID NOW CTNG Test
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:
The objective of this study is to determine the performance of the ID NOW CTNG test in male urine female urine and self-collected vaginal swabs when tested by intended users ie untrained operators ID NOW CTNG test results will be compared to results from up to three 3 FDA cleared CTNG nucleic acid amplification tests NAATs for each sample type
Detailed Description:
This is a global study and will be conducted at approximately thirty 30 US clinical study sites and up to five 5 study sites OUS in Europe UK and Africa The participating sites in the US will be in different geographical areas Up to 30 of NG positive female participants by composite Comparative Result CCR may participate from OUS sites ID NOW testing will be conducted by untrained operators ie site staff with limited or no training or hands-on experience in conducting laboratory testing
Approximately 7100 participants will be enrolled Consented participants will provide samples for ID NOW CTNG and comparator assay testing Each female participant will provide a 20-50 mL first-catch urine FCU sample one 1 self-collected vaginal swab sample SVS and three 3 clinician-collected vaginal swabs CVS Each male participant will provide a 20-50 mL first-catch urine sample Standard of care SOC samples should be collected first prior to clinical trial specimen collection SOC vaginal swab should be collected before vaginal swabs self- and clinician-collected are collected as part of the study If sites use urine as SOC then SOC urine sample can be taken from the untreated sterile urine cup provided to collect first catch urine for this study
Samples will be collected handled stored shipped and tested according to the applicable Package Inserts as appropriate The site will record the order of sample collection for each participant ID NOW CTNG testing will be conducted on fresh samples The sites will ship samples to a central laboratory for testing with up to three 3 FDA cleared CTNG nucleic acid amplification tests NAATs according to the appropriate package inserts The central laboratory may be located outside of the clinical sites country for OUS sites and thus require shipping of samples outside of the clinical sitess country as per compliance
Each urine sample will be collected in an untreated sterile urine cup provided by Sponsor The site staff will ensure the urine cup is capped and then invert the urine cup five 5 times to mix Once inverted five 5 times site staff will test 15 ml of urine directly from the specimen cup with ID NOW CTNG within two 2 hours of collection The remaining urine will be aliquoted into applicable transport tubes for each comparator method 3 tubes and one 1 retained urine sample 5mL One 1 self-collected vaginal swab will be collected and placed in Sample Elution buffer by the participant in a private clinical setting The participant will be provided with instructions on appropriate collection Three 3 additional vaginal swabs will be collected by a clinician for each of the three 3 comparator tests per Product Inserts The order in which SVS and CVS are collected will be randomized by Participant ID number For participants with an odd-numbered Participant ID the SVS will be collected first followed by the three 3 CVS For participants with an even-numbered Participant ID the three 3 CVS will be collected first followed by the SVS For comparator tests the order of CVS sample collection will be randomized Appendix B A portion 15 ml of SVS in buffer will be tested with the ID NOW CTNG test within 2 hours of sample collection ID NOW CTNG test results are investigational and will not be used for patient diagnosis or to guide treatment After ID NOW CTNG testing leftover vaginal swab eluate and urine samples will be stored at the site according to Sponsor instructions and in the case that further testing is needed shipped to an Abbott locationcentral laboratory at the Sponsors request No personally identifiable testing for human DNA will be performed on any samples obtained from this study The Abbott location or central laboratory may be located outside of the clinical sites country for OUS sites and thus require shipping of samples outside of the clinical sitess country
The Sponsor will perform data analysis The results of the ID NOW CTNG test will be presented separately for CT and NG ID NOW CTNG test results will be presented by sample type by sex and by symptomatic and asymptomatic status POC Link functionality may be established with each ID NOW Instrument for remote connectivity
Approximately 7100 participants will be enrolled Consented participants will provide samples for ID NOW CTNG and comparator assay testing Each female participant will provide a 20-50 mL first-catch urine FCU sample one 1 self-collected vaginal swab sample SVS and three 3 clinician-collected vaginal swabs CVS Each male participant will provide a 20-50 mL first-catch urine sample Standard of care SOC samples should be collected first prior to clinical trial specimen collection SOC vaginal swab should be collected before vaginal swabs self- and clinician-collected are collected as part of the study If sites use urine as SOC then SOC urine sample can be taken from the untreated sterile urine cup provided to collect first catch urine for this study
Samples will be collected handled stored shipped and tested according to the applicable Package Inserts as appropriate The site will record the order of sample collection for each participant ID NOW CTNG testing will be conducted on fresh samples The sites will ship samples to a central laboratory for testing with up to three 3 FDA cleared CTNG nucleic acid amplification tests NAATs according to the appropriate package inserts The central laboratory may be located outside of the clinical sites country for OUS sites and thus require shipping of samples outside of the clinical sitess country as per compliance
Each urine sample will be collected in an untreated sterile urine cup provided by Sponsor The site staff will ensure the urine cup is capped and then invert the urine cup five 5 times to mix Once inverted five 5 times site staff will test 15 ml of urine directly from the specimen cup with ID NOW CTNG within two 2 hours of collection The remaining urine will be aliquoted into applicable transport tubes for each comparator method 3 tubes and one 1 retained urine sample 5mL One 1 self-collected vaginal swab will be collected and placed in Sample Elution buffer by the participant in a private clinical setting The participant will be provided with instructions on appropriate collection Three 3 additional vaginal swabs will be collected by a clinician for each of the three 3 comparator tests per Product Inserts The order in which SVS and CVS are collected will be randomized by Participant ID number For participants with an odd-numbered Participant ID the SVS will be collected first followed by the three 3 CVS For participants with an even-numbered Participant ID the three 3 CVS will be collected first followed by the SVS For comparator tests the order of CVS sample collection will be randomized Appendix B A portion 15 ml of SVS in buffer will be tested with the ID NOW CTNG test within 2 hours of sample collection ID NOW CTNG test results are investigational and will not be used for patient diagnosis or to guide treatment After ID NOW CTNG testing leftover vaginal swab eluate and urine samples will be stored at the site according to Sponsor instructions and in the case that further testing is needed shipped to an Abbott locationcentral laboratory at the Sponsors request No personally identifiable testing for human DNA will be performed on any samples obtained from this study The Abbott location or central laboratory may be located outside of the clinical sites country for OUS sites and thus require shipping of samples outside of the clinical sitess country
The Sponsor will perform data analysis The results of the ID NOW CTNG test will be presented separately for CT and NG ID NOW CTNG test results will be presented by sample type by sex and by symptomatic and asymptomatic status POC Link functionality may be established with each ID NOW Instrument for remote connectivity
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