Third Eye Retroscope Randomized Clinical Evaluation

Colorectal Neoplasms Clinical Trial

— TERRACE  

Official title:

Third Eye Retroscope Randomized Clinical Evaluation (The "TERRACE" Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044732
• Other study ID #: Avantis TER-08-06
• Status: Completed
• Phase: N/A
• First received: January 6, 2010
• Last updated: August 28, 2015
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: August 2015
• Source: Avantis Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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, and might detect additional polyps that cannot be seen with the colonoscope alone.

Patients who participate as subjects in the study will undergo two complete colonoscopy procedures, a standard colonoscopy and a colonoscopy in which a Third Eye Retroscope is used along with the same colonoscope. Half of the patients will have the standard colonoscopy first followed by the Third Eye colonoscopy, and the other half will have the Third Eye procedure first.

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Device:
• Third Eye Retroscope
Device used with colonoscope to provide second, retrograde view of the colon

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Italy	Istituto Clinico Humanitas	Milan
Netherlands	University Medical Center Utrecht	Utrecht
United Kingdom	St. Mark's Hospital	London
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Baylor University Medical Center	Dallas	Texas
United States	Kansas City Veterans Administration Medical Center	Kansas City	Missouri
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Bayside Endoscopy Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Avantis Medical Systems

Countries where clinical trial is conducted

United States,  Belgium,  Italy,  Netherlands,  United Kingdom, 

References & Publications (2)

Leufkens AM, DeMarco DC, Rastogi A, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, Siersema PD; Third Eye Retroscope — View Citation

Siersema PD, Rastogi A, Leufkens AM, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, DeMarco DC. Retrograde-viewing d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection Rates for Adenomas and for Total Polyps	Numbers of polyps and adenomas detected in first and second procedures for each group	Acute - during procedure	No
Secondary	Times for Withdrawal Phase and for Complete Procedure	For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure	Acute - during procedure	No