ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy

Colon Cancer Clinical Trial

Official title:

Evaluation of Safety and Efficacy of a New Colonoscope, ProtectiScope CS, to Diagnose Large Bowel Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00715325
• Other study ID #: CSP-IL-LIT-0703_S_01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: July 13, 2008
• Last updated: September 17, 2008
• Start date: October 2008
• Est. completion date: January 2009

Study information

• Verified date: September 2008
• Source: Stryker GI Ltd.
• Contact: Ori Segol, Dr.
• Phone: +97248250359
• Email: Ori_segol[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stryker GI Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the success rate in reaching within working distance of the Cecum with no complications.		1 month	Yes
Secondary	To assess the ability to perform routine therapeutic interventions such as biopsies, polypectomies, APC etc. as compared to therapeutic interventions with standard colonoscopes found in the literature.		1 month	Yes