Enchasing Polyp Detection: The Effect of Adding Polyp Det... | NCT06116864

Studies
Enchasing Polyp Detection: The Effect of Adding Polyp Detection Attachment Device to Computer Aid Detection System.

NCT06116864

Sponsor

Marshall University

Status

Unknown status

Last Update Posted

Nov 3, 2023Actual

Enrollment

1,766Estimated

Phase

Not Applicable

Conditions

Colon Cancer Screening
Colon Cancer Surveillance

Interventions

Endocuff and GI Genius
GI Genius

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2023Actual

Primary Completion Date

Apr 1, 2025Estimated

Completion Date

Apr 15, 2025Estimated

First Submitted Date

Oct 31, 2023

First Submission Date that Met QC Criteria

Oct 31, 2023

First Posted Date

Nov 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2023

Last Update Posted Date

Nov 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Despite the widespread use of colonoscopy, the ongoing challenge of potentially missing polyps remains. Previous studies have independently shown that both Endocuff, a colonoscope attachment device for polyp detection, and Computer-Aided Detection (CADe) systems have individually demonstrated enhanced lesion detection and safety. This study seeks to evaluate the efficacy of combining the Endocuff CADe versus using CADe alone in colonoscopy procedures for colorectal cancer screening and surveillance. This research project aims to ascertain whether the synergistic application of these technologies yields superior outcomes.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,766Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endocuff + GI Genius	Experimental	Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps	Device: Endocuff and GI Genius
GI Genius	Active Comparator	GI Genius is and Computer-Aid Detection (CADe) system to detect polyps	Device: GI Genius

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endocuff and GI Genius	Device	Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps	Endocuff + GI Genius

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adenoma detection rate	It is the percentage of patients who have at least one adenoma detected during the colonoscopy	18 months

Secondary Outcomes

Measure	Description	Time Frame
Polyp detection rate		18 months
Number of cancerous lesions		18 months
Differences in polyps histology between the groups

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18
Patients scheduled for an outpatient screening or surveillance colonoscopy.

Exclusion Criteria:

Patients who require diagnostic colonoscopy (e.g.; anemia or GI bleeding).
Patients requiring deep ileal intubation.
Patients with inflammatory bowel disease.
Patients with radiotherapy-induced colitis or other severe colitis.
Patients with colonic strictures.
Patients with acute diverticulitis.
Patients with large bowel obstruction.
Patients scheduled for therapeutic colonoscopy (e.g., planned endoscopic mucosal resection for known polyps).
Patients scheduled for assessment of a known colonic lesion.
Patients with a known history of hereditary polyposis syndrome or untreated colon cancer.
Patients with a history of colon resection.
Patients on continuous anti-thrombotic therapy
Pregnancy.
Patients who are ineligible for colonoscopy due to medical or psychiatric conditions.
Patients who are vulnerable or unable to consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wesam Frandah, MD	Marshall University Joan C. Edwards School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marshall University Joan C. Edwards School of Medicine/Cabell Huntington Hospital		Huntington	West Virginia	25701	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Model Description

This is a randomized controlled trial that compares Endocuff with Gi Genius (group A) to GI Genius alone (group B) for patients who are undergoing elective outpatient colonoscopy. Patients will be randomized by a secure online randomization software that will allocate patients in a 1:1 ratio to group A or group B.