Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy

NCT01917513 | Completed Results

• 1 other identifier: G-EYE 15505
• Study Type: interventional
• Target: 1,000
• Locations: 8 countries
• Sites: 15

Brief Summary

The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition colonoscopy with that of standard high definition colonoscopy

Conditions

Adenoma; Polyps; Colorectal Cancer

Keywords

Adenoma; Polyps; CRC; Colonoscopy; Detection Yield

Outcome Measures

Primary Outcomes (1)

• Detection Rate of Adenomas and Serrated Lesions

  The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group

  Approximalty following 14 days (histology results)

Secondary Outcomes (1)

• Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events.

  Up to 14 days (histology results)

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 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
• 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 (15)

Beth Israel Deaconess Medical Center, Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Herlev Hospital

Harlev, 2730, Denmark

Location

Universitätsmedizin Johannes Gutenberg University Mainz

Mainz, 55131, Germany

Location

Universitätsklinikum Tübingen

Tübingen, D-72076, Germany

Location

Helios Dr. Horst Schmidt Kliniken (HSK)

Wiesbaden, 65199, Germany

Location

Asian Institute of Gastroenterology

Hyderabad, India

Location

Hadassah Medical Center

Jerusalem, 91999, Israel

Location

Laniado Hospital

Netanya, Israel

Location

Assaf Harofeh Medical Center

Tzrifin, 70300, Israel

Location

Vita Salute San Raffaele University - Scientific Institute San Raffaele

Milan, 20132, Italy

Location

Maastricht University Medical Centre

Maastricht, 6202AZ, Netherlands

Location

Radboud UMC

Nijmegen, 6500 HB, Netherlands

Location

Birmingham City University

Birmingham, United Kingdom

Location

Russells Hall Hospital

Dudley, United Kingdom

Location

Related Publications (1)

• Shirin H, Shpak B, Epshtein J, Karstensen JG, Hoffman A, de Ridder R, Testoni PA, Ishaq S, Reddy DN, Gross SA, Neumann H, Goetz M, Abramowich D, Moshkowitz M, Mizrahi M, Vilmann P, Rey JW, Sanduleanu-Dascalescu S, Viale E, Chaudhari H, Pochapin MB, Yair M, Shnell M, Yaari S, Hendel JW, Teubner D, Bogie RMM, Notaristefano C, Simantov R, Gluck N, Israeli E, Stigaard T, Matalon S, Vilkin A, Benson A, Sloth S, Maliar A, Waizbard A, Jacob H, Thielsen P, Shachar E, Rochberger S, Hershcovici T, Plougmann JI, Braverman M, Tsvang E, Abedi AA, Brachman Y, Siersema PD, Kiesslich R. G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos). Gastrointest Endosc. 2019 Mar;89(3):545-553. doi: 10.1016/j.gie.2018.09.028. Epub 2018 Sep 28.

  PMID: 30273591 DERIVED

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

Results Point of Contact

• Title: Prof. Ralf Kiesslich
• Organization: Helios Dr. Horst Schmidt Kliniken, Wiesbaden, Germany

ralf.kiesslich@hsk-wiesbaden.de

Study Officials

• Ralf Kiesslich, Prof.

  Helios Dr. Horst Schmidt Kliniken, Wiesbaden, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: July 30, 2013
• First Posted: August 6, 2013
• Study Start: May 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2017-12

Locations

IT (1); DE (3); DK (1); IL (3); NL (2); GB (2); IN (1); US (2)