Clinical trial NCT01549535: Polyp Detection With The Peerscope System™
Official title: Polyp Detection With The Peerscope System™: A Randomized Tandem Colonoscopy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colon Polyps and Adenomas
Colon Cancer
Lead sponsor: PeerMedical Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-09
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed description: Design:

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.

Eligibility 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.

Primary outcomes:
measure: polyp detection rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: NY
country: United States
facility: North Shore Gasstroenterology Assoiates, P.C.
state: New York
city: NY
country: United States
facility: Southshore Gasstroenterology, P.C
state: New York
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: Elisha Medical Center
city: Tel Aviv
country: Israel
facility: The Tel Aviv Sourasky Medical Center
city: Utrecht
country: Netherlands
facility: UMC
Study officials:
affiliation: Rambam Health Care Campus
name: Ian Gralnek, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Peter Siersema, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Tel Aviv Sourasky Medical Center
name: Erwin Santo, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Carmel Medical Center
name: Ori Segol, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: North Shore Gastroenterology Associates, P.C.
name: Alan Sloyer, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Southshore Gasstroenterology, P.C
name: Jay S. Fenster, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.