Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
197 participants
INTERVENTIONAL
2012-02-29
2013-07-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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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.
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
Group B (control group)
Group B (control group) will undergo a PeerScope System™ extended view colonoscopy followed immediately by a Standard view colonoscopy.
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
Yes
Sponsors
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PeerMedical Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ian Gralnek, Prof.
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Peter Siersema, Prof.
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Erwin Santo, Prof.
Role: PRINCIPAL_INVESTIGATOR
The Tel Aviv Sourasky Medical Center
Ori Segol, Dr.
Role: PRINCIPAL_INVESTIGATOR
Carmel Medical Center
Alan Sloyer, Dr.
Role: PRINCIPAL_INVESTIGATOR
North Shore Gastroenterology Associates, P.C.
Jay S. Fenster, Dr.
Role: PRINCIPAL_INVESTIGATOR
Southshore Gasstroenterology, P.C
Locations
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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
Countries
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References
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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.
Other Identifiers
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CD-1158
Identifier Type: -
Identifier Source: org_study_id