## Protocol Section
### Identification Module
**NCT ID:** NCT01199679

**Acronym:** GERD

**Brief Title:** Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD)

**Official Title:** Evaluation of Distal Esophageal and Cardia Rubber Band Ligation and Mucosectomy in the Treatment of Subjects With Gastroesophageal Reflux Disease

#### Organization Study ID Info
**ID:** 08-016
#### Organization
**Class:** INDUSTRY
**Full Name:** Cook Group Incorporated
### Status Module
#### Completion Date
**Date:** 2013-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-06-19

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-06-17

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2012-09

**Type:** ACTUAL

#### Start Date
**Date:** 2011-06

**Status Verified Date:** 2015-06

#### Study First Post Date
**Date:** 2010-09-13
**Type:** ESTIMATED
**Study First Submit Date:** 2010-09-09
**Study First Submit QC Date:** 2010-09-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Cook Group Incorporated

#### Responsible Party

**Type:** SPONSOR

### 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.

### Conditions Module

**Conditions:**

- Gastroesophageal Reflux Disease

- Heartburn

- Regurgitation

- Dyspepsia

**Keywords:**

- Gastroesophageal Reflux Disease

- Heartburn

- Regurgitation

- Dyspepsia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Mucosectomy

**Label:** Endoscopic Mucosal Resection (EMR) Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Procedure: Rubber Band Ligation

**Label:** Banding Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Endoscopic Mucosal Resection (EMR) Group

**Description:** Endoscopic mucosal resection in the upper GI tract.

**Name:** Mucosectomy

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Banding Group

**Description:** Endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

**Name:** Rubber Band Ligation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** HRQL = Health Related Quality of Life Questionnaire

**Measure:** Reduction of reflux symptoms measured by GERD HRQL

**Time Frame:** 6 months

#### Secondary Outcomes

**Measure:** Reduction in total esophageal acid exposure measured by 48 hour pH monitoring

**Time Frame:** 6 months

### 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Indianapolis

**Country:** United States

**Facility:** Indiana University Hospital

**State:** Indiana

**Zip:** 46202

#### Overall Officials

**Official 1:**

**Affiliation:** Indiana University Hospital

**Name:** Glen A. Lehman, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015154

- Term: Esophageal Motility Disorders

- ID: D000003680

- Term: Deglutition Disorders

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000004941

- Term: Esophagitis

- ID: D000005759

- Term: Gastroenteritis

- ID: D000010437

- Term: Peptic Ulcer

- ID: D000004378

- Term: Duodenal Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000013272

- Term: Stomach Diseases

- ID: D000012817

- Term: Signs and Symptoms, Digestive

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

### Condition Browse Module - Browse Leaves

- ID: M7589

- Name: Dyspepsia

- Relevance: HIGH

- As Found: Dyspepsia

- ID: M8880

- Name: Gastroesophageal Reflux

- Relevance: HIGH

- As Found: Gastroesophageal Reflux

- ID: M9444

- Name: Heartburn

- Relevance: HIGH

- As Found: Heartburn

- ID: M8091

- Name: Esophagitis

- Relevance: LOW

- As Found: Unknown

- ID: M8092

- Name: Esophagitis, Peptic

- Relevance: HIGH

- As Found: Gastroesophageal Reflux

- ID: M17874

- Name: Esophageal Motility Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17875

- Name: Esophageal Spasm, Diffuse

- Relevance: LOW

- As Found: Unknown

- ID: M6882

- Name: Deglutition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M8085

- Name: Esophageal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M13348

- Name: Peptic Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M7552

- Name: Duodenal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16062

- Name: Stomach Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005764

- Term: Gastroesophageal Reflux

- ID: D000004942

- Term: Esophagitis, Peptic

- ID: D000004415

- Term: Dyspepsia

- ID: D000006356

- Term: Heartburn

### Misc Info Module

- Version Holder: 2024-05-24
