Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study

NCT01955122 | Completed Results DMC

• 1 other identifier: TSDPR100
• Study Type: interventional
• Target: 126
• Locations: 3 countries
• Sites: 3

Brief Summary

To compare the adenoma miss rate with the EndoRings™ vs. the adenoma miss rate with Standard view colonoscopy. To compare the polyp miss rate with the EndoRings™ vs. the polyp miss rate with Standard view colonoscopy.In addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.

Conditions

Colon Cancer

Keywords

polyp/adenoma miss rate; colonoscopy add-on device; enhanced screening

Outcome Measures

Primary Outcomes (1)

• Adenoma and Polyp Miss Rate

  Group A- we measured the Adenoma\&Polyp miss rates in the first procedure with Standard (based on what we discovered on the second procedure with the EndoRings). Group B- we measured the Adenoma\&Polyp miss rates in the first procedure with EndoRings (based on what we discovered on the second procedure with the Standard). Adenoma/Polyp Miss Rate means: total number of adenomas or polyps detected during the second procedure per Group divided by the total number of adenomas/polyps detected overall per Group\]\*100

  30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total.

Secondary Outcomes (6)

• Total Number of Therapeutic Interventions Performed

  Interventions during procedure

• Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured

  During the procedure

• Sedation

  During the procedure

• Scope Centering Ability

  During the procedure

• Colon Area Screened

  During the procedure

Study Arms (2)

Group A

OTHER

Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.

Device: Tandem Colonoscopy

Group B

OTHER

Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.

Device: Tandem Colonoscopy

Interventions

Tandem Colonoscopy DEVICE

Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order.

Also known as: Colon screening

Group A; Group B

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject between the ages of 40 and 75
• The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
• Written informed consent must be available before enrollment in the trial

You may not qualify if:

• Patients with a history of colonic resection;
• Patients with known (or newly diagnosed) 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 with a hemorrhagic diathesis
• Patients with acute lower GI bleeding
• Pregnant women and women with childbearing potential without adequate contraception
• 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.

Sponsors & Collaborators

• EndoAid: lead

Study Sites (3)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Elisha Medical Center

Haifa, Please Select, 34601, Israel

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Related Publications (1)

• Dik VK, Gralnek IM, Segol O, Suissa A, Belderbos TD, Moons LM, Segev M, Domanov S, Rex DK, Siersema PD. Multicenter, randomized, tandem evaluation of EndoRings colonoscopy--results of the CLEVER study. Endoscopy. 2015 Dec;47(12):1151-8. doi: 10.1055/s-0034-1392421. Epub 2015 Jul 28.

  PMID: 26220283 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Polyps

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof. Peter Siersema
• Organization: UMC Utrecht

P.D.Siersema@umcutrecht.nl

+31 88 7559338

Study Officials

• Meytal Segev, DMD

  EndoAid Ltd.

  STUDY DIRECTOR

• Ian Gralnek, Prof.

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

• Ori Segol, Dr.

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

• Peter Siersema, Prof.

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Douglas K. Rex, Dr.

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: October 7, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 6, 2017
• Results First Posted: March 6, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); NL (1); US (1)