Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study
Public ClinicalTrials.gov record NCT02025504. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Efficacy of ColoWrap® Abdominal Binder in Improving Performance and Tolerance of Colonoscopy: a Randomized, Sham-Controlled, Blinded Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Colonoscopy is the gold-standard for colorectal cancer screening in the US. However, complete colonoscopy can be a challenging technical procedure, even for expert gastroenterologists due to variations in patient anatomy, tortuous colons, and looping of the endoscope. Such obstacles can prolong colonoscopy, lead to complications, decrease polyp detection, and impact patient experience and tolerance. The investigators propose to evaluate the efficacy of a new non-invasive abdominal binder (ColoWrap®) in improving the performance and tolerance of colonoscopy by way of a randomized, blinded clinical trial. Eligible participants undergoing colonoscopy at University of North Carolina Hospitals (UNCH) will be recruited for the study and randomized to either the ColoWrap intervention or sham arm. Colonoscopy will be performed per usual operating procedures. The primary outcome will be time to distal extent (cecal intubation time). Secondary outcomes include colonoscopy completion rate, use of ancillary maneuvers, medication usage, procedural difficulty, patient comfort, and operator and assistant fatigue and pain. Efficacy will be assessed on the basis of pairwise comparisons between groups with respect to primary and secondary outcomes.
Study identification
- NCT ID
- NCT02025504
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 350 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2014
- Primary completion
- Feb 28, 2015
- Completion
- Feb 28, 2015
- Last update posted
- Apr 2, 2015
2014 – 2015
United States locations
- U.S. sites
- 3
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UNC Hospitals | Chapel Hill | North Carolina | 27514 | — |
| UNC Meadowmont Endoscopy Center | Chapel Hill | North Carolina | 27517 | — |
| UNC Hillsborough Endoscopy Center | Hillsborough | North Carolina | 27278 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02025504, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 2, 2015 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02025504 live on ClinicalTrials.gov.