ProtectiScope CS Intended for Diagnostic and Therapeutic... | NCT00715325

Studies
ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy

NCT00715325

Sponsor

Stryker GI Ltd.

Status

Unknown status

Last Update Posted

Sep 18, 2008Estimated

Enrollment

200Estimated

Phase

Phase 1Phase 2

Conditions

Colon Cancer

Interventions

Protectiscop CS

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2008Estimated

Completion Date

Jan 2009Estimated

First Submitted Date

Jul 13, 2008

First Submission Date that Met QC Criteria

Jul 14, 2008

First Posted Date

Jul 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2008

Last Update Posted Date

Sep 18, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Device: Protectiscop CS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Protectiscop CS	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Ori Segol, Dr.	Contact	+97248250359		Ori_segol@clalit.org.il

Name	Affiliation	Role
Ori Segol, Dr.	Carmel Medical Center	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided