Rubber Band Ligation and Mucosectomy for Gastroesophageal... | NCT01199679

Studies
Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD)

NCT01199679

Sponsor

Cook Group Incorporated

Status

Terminated

Last Update Posted

Jun 19, 2015Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Gastroesophageal Reflux Disease
Heartburn
Regurgitation
Dyspepsia

Interventions

Mucosectomy
Rubber Band Ligation

Countries

United States

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Mar 2013Actual

First Submitted Date

Sep 9, 2010

First Submission Date that Met QC Criteria

Sep 10, 2010

First Posted Date

Sep 13, 2010Estimated

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

Jun 17, 2015

Last Update Posted Date

Jun 19, 2015Estimated

Description Module

Brief Summary

The purpose of this study is to determine the safety and effectiveness of two separate procedures to treat gastroesophageal reflux disease (GERD) also known as heartburn. The two therapies are: 1) a banding procedure alone using the Cook® 6 Shooter™ Saeed Multi-Band Ligator or 2) a banding/shaving procedure called Endoscopic Mucosal Resection (EMR) using the Cook® Duette™ Multi-Band Mucosectomy device.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endoscopic Mucosal Resection (EMR) Group	Experimental		Procedure: Mucosectomy
Banding Group	Experimental		Procedure: Rubber Band Ligation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mucosectomy	Procedure	Endoscopic mucosal resection in the upper GI tract.	Endoscopic Mucosal Resection (EMR) Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of reflux symptoms measured by GERD HRQL	HRQL = Health Related Quality of Life Questionnaire	6 months

Secondary Outcomes

Measure	Description	Time Frame
Reduction in total esophageal acid exposure measured by 48 hour pH monitoring		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is 18 years of age or older.
Typical symptoms of heartburn and/or regurgitation requiring daily PPI therapy.
Subject agrees to participate and signs consent form.

Exclusion Criteria:

Patient is pregnant.
Patient has a hiatal hernia greater than 2cm.
Presence of persistent daily solid food dysphagia, unplanned weight loss over ten pounds, esophageal bleeding, or vomiting more than once per week).
Active medical condition that would preclude the subject from finishing this study.
BMI > 39.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Glen A. Lehman, MD	Indiana University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana University Hospital		Indianapolis	Indiana	46202	United States

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux
D006356	Heartburn
D004415	Dyspepsia

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided