Feasibility Study to Evaluate the Performance of Floccula... | NCT01370759

Studies
Feasibility Study to Evaluate the Performance of Flocculation-Adsorption System for Colon Cleansing Enhancement

NCT01370759

Sponsor

Medtronic - MITG

Status

Terminated

Last Update Posted

Jul 31, 2019Actual

Enrollment

81Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Cleaning capsule

Countries

Israel

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

Apr 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated due to sponsor desicioun

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jun 9, 2011

First Submission Date that Met QC Criteria

Jun 9, 2011

First Posted Date

Jun 10, 2011Estimated

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

Jul 29, 2019

Last Update Posted Date

Jul 31, 2019Actual

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 demonstrate feasibility of enhancing colon cleansing.

Detailed Description

To ensure the success of a PillCamTM Colon examination, as standard practice, patients are requested to adhere to a bowel preparation procedure.

The study is designed to evaluate the performance and contribution of a flocculation-adsorption system to colon cleansing.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colon-targeted cleaning capsule	Experimental		Other: Cleaning capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cleaning capsule	Other	Capsules containing the tested materials aimed to improve colon cleansing	Colon-targeted cleaning capsule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cleansing grading		within 10 days

Secondary Outcomes

Measure	Description	Time Frame
Distribution of time		within 10 days
GI tract segment of capsule disintegration		within 10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject's age is between 23-75 years.
Subject is healthy.
Subject agrees to sign the Informed Consent Form

Exclusion Criteria:

Contraindication to capsule endoscopy
Contraindication or allergy to any of the products and materials used for bowel preparation
Subject is not able to provide written informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ian Gralnek, MD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Medical center		Haifa			Israel