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Polyp Detection With The Peerscope System™

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ClinicalTrials.gov Identifier: NCT01549535
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
PeerMedical Ltd.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colon Polyps and Adenomas Colon Cancer Device: Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Polyp Detection With The Peerscope System™: A Randomized Tandem Colonoscopy Study
Study Start Date : February 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arms and Interventions
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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
  • Polyp detection
  • Screening
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
  • Polyp detection
  • Screening


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549535


Locations
United States, New York
North Shore Gasstroenterology Assoiates, P.C.
NY, New York, United States
Southshore Gasstroenterology, P.C
NY, New York, United States
Israel
Carmel Medical Center
Haifa, Israel
Elisha Medical Center
Haifa, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Netherlands
UMC
Utrecht, Netherlands
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: PeerMedical Ltd.
ClinicalTrials.gov Identifier: NCT01549535     History of Changes
Other Study ID Numbers: CD-1158
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Polyps
Adenoma
Pathological Conditions, Anatomical
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms