Polyp Detection With The Peerscope System™
1 other identifier
interventional
197
3 countries
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2012
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 13, 2012
CompletedFirst Posted
Study publicly available on registry
March 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedNovember 25, 2016
November 1, 2016
1.1 years
February 13, 2012
November 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 year
Study Arms (2)
Group A (study group)
ACTIVE COMPARATORSubjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by a PeerScope System™ extended view colonoscopy.
Group B (control group)
ACTIVE COMPARATORGroup B (control group) will undergo a PeerScope System™ extended view colonoscopy followed immediately by a Standard view colonoscopy.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PeerMedical Ltd.lead
Study Sites (6)
North Shore Gasstroenterology Assoiates, P.C.
New York, New York, United States
Southshore Gasstroenterology, P.C
New York, New York, United States
Carmel Medical Center
Haifa, Israel
Elisha Medical Center
Haifa, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
UMC
Utrecht, Netherlands
Related Publications (1)
Gralnek IM, Siersema PD, Halpern Z, Segol O, Melhem A, Suissa A, Santo E, Sloyer A, Fenster J, Moons LM, Dik VK, D'Agostino RB Jr, Rex DK. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial. Lancet Oncol. 2014 Mar;15(3):353-60. doi: 10.1016/S1470-2045(14)70020-8. Epub 2014 Feb 20.
PMID: 24560453DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2012
First Posted
March 9, 2012
Study Start
February 1, 2012
Primary Completion
March 1, 2013
Study Completion
July 1, 2013
Last Updated
November 25, 2016
Record last verified: 2016-11