ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00715325

Enrollment

200

Registered

2008-07-15

Start date

2008-10-31

Completion date

2009-01-31

Last updated

2008-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

colonoscopy, disposable, single use

Brief summary

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

Detailed 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.

Interventions

DEVICEProtectiscop 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To determine the success rate in reaching within working distance of the Cecum with no complications.	1 month

Secondary

Measure	Time frame
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

Contacts

Primary ContactOri Segol, Dr.

Ori_segol@clalit.org.il+97248250359

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026