| Registry | NCT01601431 |
|---|---|
| Status | Terminated - Study was inactivated by the IRB since PI left institution. |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, diagnostic |
| Enrollment | 440 (Actual) |
| Sponsor | Texas Tech University Health Sciences Center, El Paso (Other) |
| Conditions | Adenoma |
| Interventions | Cap Assisted Colonoscopy, Conventional colonoscopy (Device) |
| Dates | start 2012-03-29, primary completion 2015-02-02, completion 2015-02-02, first posted 2012-05-18, last updated 2018-06-07 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Adenoma All trials of Cap Assisted Colonoscopy All trials of Conventional colonoscopy
This is a research study about the usefulness of transparent cap during screening colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will improve the detection of adenomatous polyps (polyps which can become colon cancer later on) in comparison to the standard colonoscopy.
This is a prospective, randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy. The aims of the study are:
1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
2. Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
3. Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
4. Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cap Assisted Colonoscopy | Experimental | Device: Cap Assisted Colonoscopy | Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds. |
| Conventional colonoscopy | Active comparator | Device: Conventional colonoscopy | A conventional colonoscopy does not use a Cap in order to perform the procedure |
Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers
Inclusion Criteria: * Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes. Exclusion Criteria: 1. Patients younger than 18 yrs old or older than 80 yrs. 2. Patients with a prior history of colonic surgeries 3. Patient with Crohns colitis or ulcerative colitis. 4. Patient with prior history of colon cancer 5. Patient with poor bowel preparation
| Milestone | Cap Assisted Colonoscopy | Conventional Colonoscopy |
|---|---|---|
| Started | 223 | 217 |
| Completed | 211 | 214 |
| Not completed | 12 | 3 |
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Cap Assisted Colonoscopy | 0/211 (0.0%) | 1/211 (0.5%) | 0/211 (0.0%) |
| Conventional Colonoscopy | 0/214 (0.0%) | 0/214 (0.0%) | 0/214 (0.0%) |
| Term | Organ system | Cap Assisted Colonoscopy | Conventional Colonoscopy |
|---|---|---|---|
| Perforation | Gastrointestinal disorders | 1/211 | 0/214 |
Limitations and caveats: single center study
| Facility | City | Country | Status |
|---|---|---|---|
| Texas Tech University Health Sciences Center at El Paso | El Paso, Texas | United States |