Third Eye Retroscope Randomized Clinical Evaluation (TERRACE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Colonoscopy is generally agreed to be the best method for detecting and removing pre-cancerous polyps, but some lesions can be missed, especially if they are located behind folds in the lining of the colon or behind flexures (sharp bends) in the colon.
The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon. Previous studies have shown the device to be effective for detecting additional polyps that could not have been seen with the colonoscope alone.
The purpose of this research is to compare the additional diagnostic yield obtained by using the Third Eye® Retroscope® vs. the diagnostic yield for the standard colonoscope alone in the context of a randomized, controlled study design.
Patients who are scheduled for colonoscopy will be recruited to the study and randomized to one of two groups. Each patient will undergo two "back-to-back" procedures.
Patients in Group A (study group) will undergo a standard colonoscopy followed immediately by a Third Eye colonoscopy. Patients in Group B (control group) will undergo a Third Eye colonoscopy followed immediately by a standard colonoscopy.
Results from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.
| Condition | Intervention |
|---|---|
|
Colorectal Neoplasms |
Device: Third Eye Retroscope |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Third Eye Retroscope Randomized Clinical Evaluation (The "TERRACE" Study) |
- Detection rates for adenomas and for total polyps [ Time Frame: Acute - during procedure ] [ Designated as safety issue: No ]
- Times for withdrawal phase and for complete colonoscopy procedure [ Time Frame: Acute - during procedure ] [ Designated as safety issue: No ]
| Enrollment: | 448 |
| Study Start Date: | March 2009 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A - COLO, then TER
Complete examination with standard colonoscope ("COLO") followed by complete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope
|
Device: Third Eye Retroscope
Device used with colonoscope to provide second, retrograde view of the colon
|
|
Active Comparator: Group B - TER, then COLO
Complete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope, followed by complete examination with standard colonoscope ("COLO") alone
|
Device: Third Eye Retroscope
Device used with colonoscope to provide second, retrograde view of the colon
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
- The patient must understand and provide written consent for the procedure.
Exclusion Criteria:
- Patients with a history of colonic resection;
- Patients with inflammatory bowel disease;
- Patients with a personal history of polyposis syndrome;
- Patients with suspected chronic stricture potentially precluding complete colonoscopy;
- Patients with diverticulitis or toxic megacolon;
- Patients with a history of radiation therapy to abdomen or pelvis;
- Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Missouri | |
| Kansas City Veterans Administration Medical Center | |
| Kansas City, Missouri, United States, 64128 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, Rhode Island | |
| Bayside Endoscopy Center | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| Belgium | |
| Cliniques Universitaires Saint-Luc | |
| Brussels, Belgium, B-1200 | |
| Italy | |
| Istituto Clinico Humanitas | |
| Milan, Italy, 20089 Rozzano | |
| Netherlands | |
| University Medical Center Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| United Kingdom | |
| St. Mark's Hospital | |
| London, United Kingdom, HA1 3UJ | |
| Principal Investigator: | Peter D. Siersema, MD, PhD | UMC Utrecht |
More Information
Publications:
| Responsible Party: | Avantis Medical Systems |
| ClinicalTrials.gov Identifier: | NCT01044732 History of Changes |
| Other Study ID Numbers: | Avantis TER-08-06 |
| Study First Received: | January 6, 2010 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Avantis Medical Systems:
|
Colorectal Neoplasms Adenomas Polyps |
Miss rates Detection rates Colonoscope Third Eye Retroscope |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013