Gastroesophageal Reflux DiseaseGERDNCT01199679
Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD)
A study testing Mucosectomy and Rubber Band Ligation in people with Gastroesophageal Reflux Disease and Heartburn, run by Cook Group Incorporated at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease, Heartburn, Regurgitation
- What is being tested?
- Mucosectomy and Rubber Band Ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Evaluation of Distal Esophageal and Cardia Rubber Band Ligation and Mucosectomy in the Treatment of Subjects With Gastroesophageal Reflux Disease
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
- Gastroesophageal Reflux Disease, Heartburn, Regurgitation, Dyspepsia
- Being tested
- Mucosectomy, Rubber Band Ligation
- Keywords
- Gastroesophageal Reflux Disease, Heartburn, Regurgitation, Dyspepsia
- Medical subject headings
- Gastroesophageal Reflux, Heartburn, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MucosectomyProcedure or surgery
Endoscopic mucosal resection in the upper GI tract.
Rubber Band LigationProcedure or surgery
Endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Mucosal Resection (EMR) Group | Experimental | Not described Receives: Procedure: Mucosectomy |
| Banding Group | Experimental | Not described Receives: Procedure: Rubber Band Ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of reflux symptoms measured by GERD HRQL
HRQL = Health Related Quality of Life Questionnaire
Measured: 6 months
Secondary outcomes (1)
Reduction in total esophageal acid exposure measured by 48 hour pH monitoring
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startJun 2011
- Primary completionSep 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glen A. Lehman, MD, Principal investigator, Indiana University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199679
- Sponsor's protocol ID
- 08-016
- Acronym
- GERD
- Status last verified
- Jun 2015
- First submitted
- 9 Sep 2010
- Last updated
- 19 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Distal Esophageal and Cardia Rubber Band Ligation and Mucosectomy in the Treatment of Subjects With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT01199679
- Acronym / sponsor ID
- GERD / 08-016
- Conditions
- Gastroesophageal Reflux Disease, Heartburn, Regurgitation, Dyspepsia
- Keywords
- Gastroesophageal Reflux Disease, Heartburn, Regurgitation, Dyspepsia
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Mucosal Resection (EMR) Group | Experimental | Procedure: Mucosectomy |
| Banding Group | Experimental | Procedure: Rubber Band Ligation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MucosectomyEndoscopic mucosal resection in the upper GI tract. | Procedure or surgery | Endoscopic Mucosal Resection (EMR) Group |
| Rubber Band LigationEndoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids. | Procedure or surgery | Banding Group |
Primary outcome
Reduction of reflux symptoms measured by GERD HRQL
Time frame: 6 months
HRQL = Health Related Quality of Life Questionnaire
1 secondary outcome
Reduction in total esophageal acid exposure measured by 48 hour pH monitoring
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen A. Lehman, MD principal investigator
Indiana University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucosectomy and Rubber Band Ligation in people with Gastroesophageal Reflux Disease and Heartburn, run by Cook Group Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of reflux symptoms measured by GERD HRQL (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.