Polyp Detection With The Peerscope System™: A Randomized Tandem Colonoscopy Study
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.
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™.
Incidence of device-related and procedure-related serious adverse events. Incidence of
complications using PeerScope System™
Known complications include:
- Severe abdominal pain;
- Bleeding (other than expected minor bleeding due to therapeutic procedures e.g.
- Inducing inflammation of diverticulum
- Arrhythmia, bradycardia, hypotension, hypoxia
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.
- 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
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening
polyp detection rate
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.
Ian Gralnek, Prof.
Rambam Health Care Campus
United States: Institutional Review Board
|North Shore Gasstroenterology Assoiates, P.C.||NY, New York|
|Southshore Gasstroenterology, P.C||NY, New York|