MDACC Study Summary 2007-0246 (Archived)

Study Summary
No. 2007-0246:.......Colorectal......Robert S. Bresalier......Gastroenterology/Hepatology and Nutrition

Study Summary Title



Study Summary Number:	2007-0246

Study Title:	A Prospective Efficacy Evaluation of the Third EyeTM RetroscopeTM Auxiliary Imaging System

Physician

New Patient Referral



Name:	Robert S. Bresalier	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gastroenterology/Hepatology and Nutrition	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-5073 Contact us about clinical trials

General Information



Disease Group:	Colorectal	Supported By:	Avantis Medical Systems Incorporated

Phase of Study:	N/A	Return Visit:	There are no return visit required by this protocol.

Treatment Agents:	None	Home Care:	No treatment is given at home to particpants in this study.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	This procecedure will be performed on outpatients and therefore will not require hospitalization. Participation in this study will not increase the length or frequency of hospitalization


Description/ Intervention:	The goal of this clinical research study is to find out if the Third Eye Retroscope device can help researchers to detect abnormal lesions located in areas that are difficult to see with a colonoscope (the tube instrument used in routine colonoscopies).

Study Objectives / Outcomes

The purpose of this study is to demonstrate efficacy of the Avantis Third Eye Retroscope auxiliary imaging system.

The primary objective of this study is to assess the degree to which incorporating the Third Eye Retroscope auxiliary imaging system in a screening colonoscopy setting results in the detection of additional polyps. Specifically, the primary goals are to estimate (1) the proportion of polyps detected under this protocol that would have been missed without the Third Eye Retroscope, and (2) the proportion of patients found under this protocol to have polyps who would have incorrectly been classified as polyp-free had the Third Eye Retroscope not been used.

Information gained from this study will include:

· Data regarding efficacy of the device for detecting abnormal lesions located in areas that are difficult to visualize with a colonoscope, such as the proximal aspect of haustral folds, rectal valves, flexures and the ileocecal valve;

Impressions of endoscopists regarding usability and ergonomic factors.

(Beginning of Rationale)

Avantis Medical Systems, Inc. has designed an auxiliary imaging device that can be inserted through the instrument channel of a colonoscope so that it extends beyond the tip of the colonoscope and provides a continuous retrograde view during withdrawal of the colonoscope.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	03/05/2008

Study Type:	Other

Recruitment Status:	Terminated

Projected Accrual:	700

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) The patient is undergoing colonoscopy for screening purposes or for surveillance in follow-up for previous polypectomy;

2) The patient is at satisfactory risk for abdominal surgery;

3) The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

1) Patients who are <50 years or >80 years of age

2) Patients who are pregnant;

3) Patients with history of colonic resection;

4) Patients requiring ongoing anticoagulation therapy;

5) Patients with a history of severe cardiovascular, pulmonary, liver or renal disease;

6) Patients with hypersensitivity to opioid analgesics;

7) Patients with an active systemic infection;

8) Patients with suspected chronic stricture potentially precluding complete colonoscopy;

9) Patients with major psychiatric disease (dementia, schizophrenia or depression);

10) Patients with diverticulitis or toxic megacolon;

11) Patients with history of radiation therapy to abdomen or pelvis.

12) 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.

Links

Registration Number: NCT00657371
Study Information on Clinical Trials Registry (clinicaltrials.gov)