Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy

NCT02545699 | Unknown

• 1 other identifier: G-EYE 15507
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the adenoma detection rate (ADR) of the G-EYE™ colonoscopy with that of standard colonoscopy.

Conditions

Adenoma; Polyps; Colorectal Cancer

Keywords

Adenoma; Polyp; CRC; Colonoscopy; Detection Yield

Outcome Measures

Primary Outcomes (1)

• G-EYE™ Colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same

  Approximately following 14 days (histology results)

Secondary Outcomes (3)

• Polyp and adenoma detection

  Up to 14 days (Histology results)

• Procedure times

  At time of procedure

• Safety (number of patients with adverse events)

  48-72 hours

Study Arms (2)

G-EYE™ Colonoscopy

EXPERIMENTAL

G-EYE™ Colonoscopy

Device: G-EYE™ Colonoscopy

Standard Colonoscopy

ACTIVE COMPARATOR

Standard Colonoscopy

Device: Standard Colonoscopy

Interventions

G-EYE™ Colonoscopy DEVICE

G-EYE™ Colonoscopy

G-EYE™ Colonoscopy

Standard Colonoscopy DEVICE

Standard Colonoscopy

Standard Colonoscopy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 50 years old
• Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits, for diagnostic evaluation or for surveillance colonoscopy (history of adenoma resection).
• The patient must understand and provide written consent for the procedure.

You may not qualify if:

• Subjects with inflammatory bowel disease;
• Subjects with a personal history of polyposis syndrome;
• Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
• Subjects with diverticulitis or toxic megacolon;
• Subjects with a history of radiation therapy to abdomen or pelvis;
• Pregnant or lactating female subjects;
• Subjects who are currently enrolled in another clinical investigation.
• Subjects with current oral or parenteral use of anticoagulants that have not stopped using anticoagulants as required by the guidelines of the medical center;
• Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
• Any patient condition deemed too risky for the study by the investigator
• Previous colonic surgery (except for appendectomy)

Sponsors & Collaborators

• Smart Medical Systems Ltd.: lead

Study Sites (1)

Bnai Zion Hospital

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Adenoma; Polyps; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Tova Rainis, Dr.

  Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tova Rainis, Dr.

CONTACT

04-8359426; tovarainis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 10, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 7, 2016

Record last verified: 2016-06

Locations

IL (1)