MedDataX Logo

ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy

NCT ID: NCT00715325

Last Updated: 2008-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether the ProtectiScope CS is capable to perform diagnostic and therapeutic colonoscopy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The ProtectiScope CS is a disposable-based colonoscope incorporating a miniature video camera,integral light source along with single-use sleeves and application Channels.

The ProtectiScope CS is intended to provide visualization and therapeutic access to the Lower Gastrointestinal Tract, in adult patient populations.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

colonoscopy disposable single use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

Protectiscop CS

Intervention Type DEVICE

Patients who are indicated for screening colonoscopy will be recruited into the trial. The ProtectiScope CS sleeve is assembled on the colonoscope.standard colonoscopy is performed. Subjects will be followed for 1-month post procedure.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Protectiscop CS

Patients who are indicated for screening colonoscopy will be recruited into the trial. The ProtectiScope CS sleeve is assembled on the colonoscope.standard colonoscopy is performed. Subjects will be followed for 1-month post procedure.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject between the ages of 18 and 80
* Subject is indicated for screening colonoscopy
* Subject is willing to sign informed consent form

Exclusion Criteria

* Subject is suspected, based on radiographic or other clinical grounds, of suffering from one or more of the following: full or partial colonic obstruction; acute abdomen; gross hematochezia; severely ulcerated colon; diverticulitis; severe diverticulosis; toxic megacolon.
* Subject has active cardiac problems and history of heart failure, severe pulmonary diseases renal failure (creatinine \>2) uncontrolled diabetes and any other illness judged by investigator to substantiate exclusion.
* Subject has a history of significant other diseases.
* Subject has a history of psychiatric disorders which would prevent compliance with study instructions
* For female subjects, suspicion of pregnancy
* Subject has received treatment with another investigational drug or device within the past 30 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stryker GI Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carmel Nedical Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ori Segol, Dr.

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ori Segol, Dr.

Role: CONTACT

Phone: +97248250359

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSP-IL-LIT-0703_S_01

Identifier Type: -

Identifier Source: org_study_id