NCT01483040

Brief Summary

The PeerScope B System™ by PeerMedical Ltd. is intended to provide visualization (via a video monitor) and therapeutic access to the lower intestinal tract. The lower intestinal tract includes, but is not restricted to the organs, tissues and subsystems: large bowel and cecum. The device is introduced rectally, as with any standard colonoscope when indications consistent with the need for the procedure are observed in the adult patient population. The purpose of this prospective clinical study is to establish the usability of the PeerScope B System™ when used during standard colonoscopy procedure. The study population is comprised of patients indicated for colonoscopy. The primary endpoint is reaching the cecum of the colon with PeerScope B System™.Secondary endpoints:

  1. 1.The first secondary endpoint is the incidence of complications using the PeerMedical colonoscope.
  2. 2.The second secondary endpoint is successful therapeutic interventions as biopsies, polypectomies, APC etc.
  3. 3.The third secondary endpoint is the procedure time.
  4. 4.The fourth secondary endpoint is the subjective evaluation of the additional view angle by the physician.
  5. 5.The fifth secondary endpoint is patient satisfactory.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
Last Updated

November 8, 2012

Status Verified

November 1, 2012

Enrollment Period

2 months

First QC Date

November 22, 2011

Last Update Submit

November 7, 2012

Conditions

Colon CancerColon DiseasesColon PolypsColon Adenomas

Keywords

wide angle view colonoscopyPeerScope B System™

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is reaching the cecum of the colon with PeerScope B S

    a full colonoscopy procedure is characterized by reaching an anatomical mark (cecum)at the end of the insertion phase and then the physician start the withdrawal screening phase

    6 month

Interventions

colonoscopy system (PeerScope B System™)DEVICE

Cancer of the colon and rectum is second only to lung cancer as the leading cause of cancer-related deaths in the United States.Each year, about 1.23 million new cases of bowel cancer are diagnosed worldwide, 333,000 in Europe alone. Colorectal cancer almost always starts in a benign growth called a polyp. Polyps originate in the inner lining of the colon, where they may be visible in a screening test known as colonoscopy. Recent research has shown that appropriate screening and treatment can alleviate much of the suffering associated with colorectal cancer and reduce the number of deaths caused by this malignancy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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 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 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

Study Sites (1)

Elisha Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Colonic NeoplasmsColonic DiseasesColonic Polyps

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesIntestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ian Gralnek, Prof.

    Ministry of Health, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2011

First Posted

December 1, 2011

Study Start

September 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 8, 2012

Record last verified: 2012-11

Locations

IL(1)