GERDCLEARNCT04771247
Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy
A study testing Cardia Band Ligation in people with GERD and Bariatric Surgery, run by Johns Hopkins University.
Trial summary
GERD is a prevalent condition worldwide, estimated to be around 20-30 % in North America. Obesity is rapidly increasing with an estimated prevalence of 66% in the adult population in the United States. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- GERD, Bariatric Surgery, Laparoscopic Sleeve Gastrectomy
- What is being tested?
- Cardia Band Ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Sep 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese patients who underwent surgical bariatric weight loss procedures with post-surgical GERD (LSG), not responding to once daily PPI therapy.
- Obese patients who underwent surgical bariatric weight loss procedures with post-surgical GERD (LSG) who respond to maximum therapy with PPI + H2 blocker but are PPI averse or who refuse surgical therapy (conversion to RYGBP).
- Patients older than 18 years and younger than 75 years of age at time of consent.
- Patients able to provide written informed consent on the IRB/EC-approved informed consent form
- Patients willing and able to comply with study requirements for follow-up
Who cannot join
- Any patient with no prior surgical bariatric intervention.
- Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline EGD.
- Esophageal, gastric or duodenal malignancy.
- Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
- Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
- Active fungal esophagitis, Grade C or D esophagitis.
Show all 16Show fewer
- Hiatal hernias > 2 cm or para-esophageal hernias.
- Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices.
- General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation.
- Pregnant or planning to become pregnant during period of study participation.
- Patient refuses or is unable to provide written informed consent.
- Prior surgical or endoscopic anti-reflux procedure.
- Persistent dysphagia score greater than 0.
- Vomiting more than once a week.
- Biopsy-proven Barrett's esophagus.
- HREM showing marked ineffective esophageal motility (defined by ≥ 5 weak or failed swallows per Chicago Classification v 3.0), esophagogastric outflow obstruction (EGJOO) or achalasia.
About this study
Official title: Endoscopic Cardiac Band Ligation (CLEAR) Without Sleeve Stenosis for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy (LSG)
GERD is a prevalent condition worldwide, estimated to be around 20-30 % in North America. Obesity is rapidly increasing with an estimated prevalence of 66% in the adult population in the United States. Presently, bariatric interventions are the only sustainable method to address morbid obesity and its resulting comorbidities. One of the most common restrictive surgeries includes laparoscopic sleeve gastrectomy (LSG). Although very effective for treating obesity, some of these surgeries might cause deleterious effects regarding GERD, due to anatomical modifications. Refractory GERD is defined by lack of symptom control on maximum dose of PPI therapy. Cardia Band Ligation Anti-reflux (CLEAR) procedure utilizes multiple band ligations at the cardia in a 270-degree fashion, resulting in tissue necrosis and scar formation, narrowing the GE junction and enhancing the flap valve system. The investigators hypothesized that CLEAR can be a safe and efficient intervention to improve post bariatric GERD.
Read the detailed description
GERD is a prevalent condition worldwide, estimated to be around 20-30 % in North America. Obesity is rapidly increasing with an estimated prevalence of 66% in the adult population in the United States. GERD symptoms are common in the obese population with data showing weekly GERD symptoms in 34.6% and erosive esophagitis 26.9% in people with BMI > 30 Kg/m^2. Reflux is associated with complications such as esophagitis, Barrett's Esophagus and ultimately esophageal adenocarcinoma. Presently, bariatric interventions are the only sustainable method to address morbid obesity and its resulting comorbidities. There are endoscopic and surgical bariatric interventions. Bariatric surgery has been shown to be an effective and efficient means of achieving significant weight loss in obese individuals. One of the most common restrictive surgeries includes laparoscopic sleeve gastrectomy (LSG). Although very effective for treating obesity, some of these surgeries might cause deleterious effects regarding GERD, due to anatomical modifications. LSG can increase the incidence of GERD, which may be explained from the changes in the angle of His and by increasing intragastric pressure. Pharmacological therapy with proton pump inhibitors (PPI), H2 blockers and lifestyle changes are first line forms of treatment utilized to control the symptoms related to GERD. However, patients who use pharmacological treatment experience reduction in quality of life and seek alternative options. Refractory GERD is defined by lack of symptom control on maximum dose of PPI therapy. Moreover, due to the anatomical changes associated with bariatric surgeries, the traditional surgical and endoscopic techniques (TIF, Nissen Fundoplication) used to treat GERD in the general population are not suitable for these patients. With the current trend of an increase of bariatric surgery and thus GERD that arises after these surgeries, new innovative techniques to treat GERD are needed, especially in PPI averse or non-responsive patients. Cardia Band Ligation Anti-reflux (CLEAR) procedure utilizes multiple band ligations at the cardia in a 270-degree fashion, resulting in tissue necrosis and scar formation, narrowing the GE junction and enhancing the flap valve system. The investigators will perform CLEAR by placing 4 bands at the GEJ. The investigators hypothesized that CLEAR can be a safe and efficient intervention to improve post bariatric GERD.
- Conditions
- GERD, Bariatric Surgery, Laparoscopic Sleeve Gastrectomy
- Being tested
- Cardia Band Ligation
- Keywords
- CLEAR, Antireflux procedure, LSG, GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardia Band LigationProcedure or surgery
Patients will undergo cardia band ligation at the level of the GEJ.
| Study group | Role | What they receive |
|---|---|---|
| CLEAR | Experimental | Patients with GERD post LSG will undergo CLEAR (cardia band ligation). Receives: Procedure: Cardia Band Ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GERD-HQRL/RSI score
Change in symptoms assessed by GERD-HQRL/RSI score at 6 months.
Measured: Baseline and 6 months
Change in pH monitoring
Change in objective pH monitoring at 6 months.
Measured: Baseline and 6 months
Secondary outcomes (6)
Mean change on the percentage of acid exposure time (% AET)
Changes in acid exposure time from baseline.
Measured: Baseline and 6 months
Safety of CLEAR procedure as assessed by treatment-related adverse events
Assess overall safety (treatment-related adverse events) of CLEAR procedure defined by the ASGE-Lexicon classification.
Measured: Up to 6 months
Rate of dysphagia post CLEAR
Percentage of patients who develop dysphagia of any grade, associated with esophageal or gastric cardia stricture requiring dilation after CLEAR procedure.
Measured: 6-12 months
PPI discontinuation
Percentage of patients who no longer require PPI at 6 months post CLEAR.
Measured: 6 months
PPI discontinuation
Percentage of patients who no longer require PPI at 12 months post CLEAR.
Measured: 12 months
Treatment failure
Defined as less than 50% improvement in GERD HQRL/RSI score or 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 posted25 Feb 2021
- Study startSep 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: IRB approval withheld
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single center, pilot clinical trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olaya I Brewer Gutierrez, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771247
- Sponsor's protocol ID
- IRB00277820
- Acronym
- CLEAR
- Status last verified
- Sep 2021
- First submitted
- 23 Feb 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seleem WM, Hanafy AS, Mohamed SI. Endoscopic management of refractory gastroesophageal reflux disease. Scand J Gastroenterol. 2018 Apr;53(4):390-397. doi: 10.1080/00365521.2018.1445775. Epub 2018 Feb 28.
PubMed 29488430
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Cardiac Band Ligation (CLEAR) Without Sleeve Stenosis for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy (LSG)
- ClinicalTrials.gov ID
- NCT04771247
- Acronym / sponsor ID
- CLEAR / IRB00277820
- Conditions
- GERD, Bariatric Surgery, Laparoscopic Sleeve Gastrectomy
- Keywords
- CLEAR, Antireflux procedure, LSG, GERD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB approval withheld
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 25 Feb 2021 (actual)
- 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.
GERD is a prevalent condition worldwide, estimated to be around 20-30 % in North America. Obesity is rapidly increasing with an estimated prevalence of 66% in the adult population in the United States. Presently, bariatric interventions are the only sustainable method to address morbid obesity and its resulting comorbidities. One of the most common restrictive surgeries includes laparoscopic sleeve gastrectomy (LSG). Although very effective for treating obesity, some of these surgeries might cause deleterious effects regarding GERD, due to anatomical modifications. Refractory GERD is defined by lack of symptom control on maximum dose of PPI therapy. Cardia Band Ligation Anti-reflux (CLEAR) procedure utilizes multiple band ligations at the cardia in a 270-degree fashion, resulting in tissue necrosis and scar formation, narrowing the GE junction and enhancing the flap valve system. The investigators hypothesized that CLEAR can be a safe and efficient intervention to improve post bariatric GERD.
Detailed description
GERD is a prevalent condition worldwide, estimated to be around 20-30 % in North America. Obesity is rapidly increasing with an estimated prevalence of 66% in the adult population in the United States. GERD symptoms are common in the obese population with data showing weekly GERD symptoms in 34.6% and erosive esophagitis 26.9% in people with BMI > 30 Kg/m^2. Reflux is associated with complications such as esophagitis, Barrett's Esophagus and ultimately esophageal adenocarcinoma. Presently, bariatric interventions are the only sustainable method to address morbid obesity and its resulting comorbidities. There are endoscopic and surgical bariatric interventions. Bariatric surgery has been shown to be an effective and efficient means of achieving significant weight loss in obese individuals. One of the most common restrictive surgeries includes laparoscopic sleeve gastrectomy (LSG). Although very effective for treating obesity, some of these surgeries might cause deleterious effects regarding GERD, due to anatomical modifications. LSG can increase the incidence of GERD, which may be explained from the changes in the angle of His and by increasing intragastric pressure. Pharmacological therapy with proton pump inhibitors (PPI), H2 blockers and lifestyle changes are first line forms of treatment utilized to control the symptoms related to GERD. However, patients who use pharmacological treatment experience reduction in quality of life and seek alternative options. Refractory GERD is defined by lack of symptom control on maximum dose of PPI therapy. Moreover, due to the anatomical changes associated with bariatric surgeries, the traditional surgical and endoscopic techniques (TIF, Nissen Fundoplication) used to treat GERD in the general population are not suitable for these patients. With the current trend of an increase of bariatric surgery and thus GERD that arises after these surgeries, new innovative techniques to treat GERD are needed, especially in PPI averse or non-responsive patients. Cardia Band Ligation Anti-reflux (CLEAR) procedure utilizes multiple band ligations at the cardia in a 270-degree fashion, resulting in tissue necrosis and scar formation, narrowing the GE junction and enhancing the flap valve system. The investigators will perform CLEAR by placing 4 bands at the GEJ. The investigators hypothesized that CLEAR can be a safe and efficient intervention to improve post bariatric GERD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single center, pilot clinical trial
| Arm | Type | Receives |
|---|---|---|
| CLEAR | Experimental | Procedure: Cardia Band LigationPatients with GERD post LSG will undergo CLEAR (cardia band ligation). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Obese patients who underwent surgical bariatric weight loss procedures with post-surgical GERD (LSG), not responding to once daily PPI therapy.
- Obese patients who underwent surgical bariatric weight loss procedures with post-surgical GERD (LSG) who respond to maximum therapy with PPI + H2 blocker but are PPI averse or who refuse surgical therapy (conversion to RYGBP).
- Patients older than 18 years and younger than 75 years of age at time of consent.
- Patients able to provide written informed consent on the IRB/EC-approved informed consent form
- Patients willing and able to comply with study requirements for follow-up
Key exclusion criteria (16 listed)
- Any patient with no prior surgical bariatric intervention.
- Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline EGD.
- Esophageal, gastric or duodenal malignancy.
- Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
- Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
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 |
|---|---|---|
| Cardia Band LigationPatients will undergo cardia band ligation at the level of the GEJ. | Procedure or surgery | CLEAR |
Primary outcome
Change in GERD-HQRL/RSI score
Time frame: Baseline and 6 months
Change in symptoms assessed by GERD-HQRL/RSI score at 6 months.
Change in pH monitoring
Time frame: Baseline and 6 months
Change in objective pH monitoring at 6 months.
6 secondary outcomes
Mean change on the percentage of acid exposure time (% AET)
Time frame: Baseline and 6 months
Safety of CLEAR procedure as assessed by treatment-related adverse events
Time frame: Up to 6 months
Rate of dysphagia post CLEAR
Time frame: 6-12 months
PPI discontinuation
Time frame: 6 months
PPI discontinuation
Time frame: 12 months
Treatment failure
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 29488430Seleem WM, Hanafy AS, Mohamed SI. Endoscopic management of refractory gastroesophageal reflux disease. Scand J Gastroenterol. 2018 Apr;53(4):390-397. doi: 10.1080/00365521.2018.1445775. Epub 2018 Feb 28.
- Individual participant dataSharing planned: No
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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.
Olaya I Brewer Gutierrez principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Cardia Band Ligation in people with GERD and Bariatric Surgery, run by Johns Hopkins University.
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 5 inclusion and 16 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: withdrawn, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Change in GERD-HQRL/RSI score (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771247, which also lists 1 linked publication.
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 28 Sep 2021.