Polyp Detection With The Peerscope System™
This study is currently recruiting participants.
Verified November 2012 by PeerMedical Ltd.
Sponsor:
PeerMedical Ltd.
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colon Polyps and Adenomas Colon Cancer |
Device: Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Screening |
| Official Title: | Polyp Detection With The Peerscope System™: A Randomized Tandem Colonoscopy Study |
Resource links provided by NLM:
Further study details as provided by PeerMedical Ltd.:
Primary Outcome Measures:
- 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.
| Estimated Enrollment: | 196 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
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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.
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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:
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549535
Contacts
| Contact: Ian Gralnek, Prof. | 972-4-854-1680 | i_gralnek@rambam.health.gov.il |
Locations
| United States, New York | |
| North Shore Gasstroenterology Assoiates, P.C. | Not yet recruiting |
| NY, New York, United States | |
| Contact: Alan Sloyer, Dr. 516-487-2444 slowyea@gmail.com | |
| Principal Investigator: Alan Sloyer, Dr. | |
| Southshore Gasstroenterology, P.C | Not yet recruiting |
| NY, New York, United States | |
| Contact: Jay S. Fenster, Dr. 516-374-0670 jsfl@aol.com | |
| Principal Investigator: Jay S. Fenster, Dr. | |
| Israel | |
| Elisha Medical Center | Recruiting |
| Haifa, Israel | |
| Contact: Ian Gralnek, Prof. 972-4-854-1680 i_gralnek@rambam.health.gov.il | |
| Principal Investigator: Ian Gralnek, Prof. | |
| Carmel Medical Center | Not yet recruiting |
| Haifa, Israel | |
| Contact: Ori Segol, Dr. ori.segol@gmail.com | |
| Principal Investigator: Ori Segol, Dr. | |
| The Tel Aviv Sourasky Medical Center | Not yet recruiting |
| Tel Aviv, Israel | |
| Contact: Erwin Santo, Prof. erwins@tasmc.health.gov.il | |
| Principal Investigator: Erwin Santo, Prof. | |
| Netherlands | |
| UMC | Not yet recruiting |
| Utrecht, Netherlands | |
| Contact: Peter Siersema, Prof. +31-88-755-9338 P.D.Siersema@umcutrecht.nl | |
| Principal Investigator: Peter Siersema, Prof. | |
Sponsors and Collaborators
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: | 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 |
More Information
No publications provided
| Responsible Party: | PeerMedical Ltd. |
| ClinicalTrials.gov Identifier: | NCT01549535 History of Changes |
| Other Study ID Numbers: | CD-1158 |
| Study First Received: | February 13, 2012 |
| Last Updated: | November 4, 2012 |
| Health Authority: | United States: Institutional Review Board Netherlands: Dutch Health Care Inspectorate Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Adenoma Colonic Neoplasms Colonic Polyps Polyps Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Colorectal Neoplasms Intestinal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Intestinal Polyps Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 21, 2013