NCT03016962

Brief Summary

The potential benefit of using the cap is that it helps in luminal orientation at bends by keeping the colonic mucosa away from the lens at the colonoscope tip. Colonoscopy in patients with a history of abdominal surgery is considered to be difficult due to adhesion-related bowel angulations. There were few study evaluating usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery. The investigators designed a randomized, controlled trial to verify the usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,046

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

2.9 years

First QC Date

January 9, 2017

Last Update Submit

January 9, 2017

Conditions

Insertion Time

Outcome Measures

Primary Outcomes (1)

  • Insertion time

    Day 1

Secondary Outcomes (2)

  • Patient discomfort

    Day 1

  • Overall technical ease

    Day 1

Study Arms (2)

Cap-assisted colonoscopy

EXPERIMENTAL

cap-assisted colonoscopy

Device: cap-assisted colonoscopy

Standard colonoscopy

ACTIVE COMPARATOR

Standard colonoscopy

Device: Standard colonoscopy

Interventions

cap-assisted colonoscopyDEVICE

cap-assisted colonoscopy

Cap-assisted colonoscopy
Standard colonoscopyDEVICE

Standard colonoscopy

Standard colonoscopy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with history of abdominal or pelvic surgery

You may not qualify if:

  • Previous colorectal resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 11, 2017

Study Start

February 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

January 11, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share