Polyp Detection With The Peerscope System™

November 22, 2016 updated by: PeerMedical Ltd.

Polyp Detection With The Peerscope System™: A Randomized Tandem Colonoscopy Study

The PeerScope System consists of Peer Medical camera heads, endoscopes, video system, light source and other ancillary equipment. The system is intended for endoscopic diagnosis, treatment and video observation of the digestive tract. The PeerScope system model B is indicated for use for endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients.

Objective:To compare the additional diagnostic yield obtained by using the PeerScope System™ extended view vs. the diagnostic yield obtained by the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Design:

Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures.

Subjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by a PeerScope System™ extended view colonoscopy. Subjects in Group B (control group) will undergo a PeerScope System™ extended view colonoscopy followed immediately by a Standard view colonoscopy.

Results from the two groups will be analyzed and compared, with primary outcome measures being detection rates for total polyps and detection rates for adenomas. Secondary outcome measures will include withdrawal time, total procedure time and characteristics of polyps detected, including size and histological results.

Subjects will be followed through a 24 hour and a 7 days telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.

Study Design:

Multi-center study with up to 196 patients. No. of Patients:

Up to 196 treated patients will be enrolled into the study. Primary Performance Endpoint:

  • Standard view colonoscopy adenoma overall detection rate compared to the extended view overall adenoma detection rate using the PeerScope System™
  • Standard view colonoscopy overall polyp detection rate compared to the extended view overall polyp detection rate using the PeerScope System™.

Safety Analysis:

Incidence of device-related and procedure-related serious adverse events. Incidence of complications using PeerScope System™

Known complications include:

  • Perforation;
  • Severe abdominal pain;
  • Infection;
  • Bleeding (other than expected minor bleeding due to therapeutic procedures e.g. polypectomy);
  • Inducing inflammation of diverticulum
  • Arrhythmia, bradycardia, hypotension, hypoxia
  • Death

Secondary Endpoints / Other Outcomes:

  1. Performance of therapeutic interventions, such as biopsies, polypectomies, APC etc.
  2. Procedure time. The following will be recorded: a. Time for intubation to the cecum. b. Time for withdrawal from the cecum to the anal verge. c. Total 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
  3. Sedation dosage
  4. Patient satisfaction. Patient's pain at the end of the procedure will be recorded using VAS scale. Results of 24 hour telephone follow-up to assess for post-procedural patient satisfactory will be recorded on the CRF.

Inclusion criteria:

  • Subject between the ages of 18 and 70
  • 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
  • For women with childbearing potential, adequate contraception

Exclusion criteria:

  • 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 acute lower GI bleeding
  • 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 Type

Interventional

Enrollment (Actual)

197

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Carmel Medical Center
      • Haifa, Israel
        • Elisha Medical Center
      • Tel Aviv, Israel
        • The Tel Aviv Sourasky Medical Center
  • Netherlands
      • Utrecht, Netherlands
        • UMC
  • United States
    • New York
      • NY, New York, United States
        • North Shore Gasstroenterology Assoiates, P.C.
      • NY, New York, United States
        • Southshore Gasstroenterology, P.C

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject between the ages of 18 and 70
  • 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
  • For women with childbearing potential, adequate contraception

Exclusion Criteria:

  • 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 acute lower GI bleeding
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A (study group)
Subjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by a PeerScope System™ extended view colonoscopy.
Device: Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system
endoscopic diagnosis, treatment and video observation of the digestive tract, endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients
Other Names:
  • Colonoscopy
  • Screening
  • Polyp detection
ACTIVE_COMPARATOR: Group B (control group)
Group B (control group) will undergo a PeerScope System™ extended view colonoscopy followed immediately by a Standard view colonoscopy.
Device: Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system
endoscopic diagnosis, treatment and video observation of the digestive tract, endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients
Other Names:
  • Colonoscopy
  • Screening
  • Polyp detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
polyp detection rate
Time Frame: 1 year

Sample size calculation is based on detecting a difference in the adenoma overall detection rate and the overall polyp detection rate using the PeerScope System™ extended view as compared to Standard view colonoscopy.

Total sample size will be 196 patients. Each patient will undergo the procedure by the two devices: PeerScope System™ extended view and Standard view colonoscopy. The rational for this sample size is based on detecting a rate difference of 20% between the study devices.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PeerMedical Ltd.

Investigators

  • Principal Investigator: Ian Gralnek, Prof., Rambam Health Care Campus
  • Principal Investigator: Peter Siersema, Prof., UMC Utrecht
  • Principal Investigator: Erwin Santo, Prof., The Tel Aviv Sourasky Medical Center
  • Principal Investigator: Alan Sloyer, Dr., North Shore Gastroenterology Associates, P.C.
  • Principal Investigator: Jay S. Fenster, Dr., Southshore Gasstroenterology, P.C

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (ESTIMATE)

March 9, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-1158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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