Polyp Detection With The Peerscope System™

This study is currently recruiting participants.
Verified November 2012 by PeerMedical Ltd.
Sponsor:
Information provided by (Responsible Party):
PeerMedical Ltd.
ClinicalTrials.gov Identifier:
NCT01549535
First received: February 13, 2012
Last updated: November 4, 2012
Last verified: November 2012

February 13, 2012
November 4, 2012
February 2012
August 2013   (final data collection date for primary outcome measure)
polyp detection rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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.

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Complete list of historical versions of study NCT01549535 on ClinicalTrials.gov Archive Site
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Polyp Detection With The Peerscope System™
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
  • Colon Polyps and Adenomas
  • Colon Cancer
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
  • Polyp detection
  • Screening
  • 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.
    Intervention: Device: Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system
  • 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.
    Intervention: Device: Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
196
October 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
Yes
Contact: Ian Gralnek, Prof. 972-4-854-1680 i_gralnek@rambam.health.gov.il
United States,   Israel,   Netherlands
 
NCT01549535
CD-1158
Not Provided
PeerMedical Ltd.
PeerMedical Ltd.
Not Provided
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: Ori Segol, Dr. Carmel Medical Center
Principal Investigator: Alan Sloyer, Dr. North Shore Gastroenterology Associates, P.C.
Principal Investigator: Jay S. Fenster, Dr. Southshore Gasstroenterology, P.C
PeerMedical Ltd.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP