ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy

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Stryker

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Colon Cancer

Treatments

Device: Protectiscop CS

Study type

Interventional

Funder types

Industry

Identifiers

NCT00715325
CSP-IL-LIT-0703_S_01

Details and patient eligibility

About

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

Full description

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

A
Experimental group
Treatment:
Device: Protectiscop CS

Trial contacts and locations

0

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Central trial contact

Ori Segol, Dr.

Data sourced from clinicaltrials.gov

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