Gastro Esophageal Reflux DiseaseNCT05678491
Endoscopic Treatment of Gastroesophageal Reflux Disease
A study testing Endoscopic mucosal band ligation in people with Gastro Esophageal Reflux Disease, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Gastroesophageal reflux disease (GERD) occurs when stomach acid repeatedly flows back into the tube connecting your mouth and stomach (esophagus). This backwash (acid reflux) can irritate the inner lining of the esophagus. This is a particular problem after surgery to reduce obesity called gastric sleeve resection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastro Esophageal Reflux Disease
- What is being tested?
- Endoscopic mucosal band ligation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- 1 Aug 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous gastric sleeve resection
- GERD. GERD must be diagnosed by either endoscopic esophagitis or esophageal pH measurement with DeMeester score > 14.72 and pH <4 more than 4% of a 24-h period and symptom association probability (SAP) > 95%
- Subjective insufficient symptom control with PPI therapy once daily or intolerance to PPI or desire to stop PPI treatment and therefore willingness to undergo endoscopic treatment.
Who cannot join
- Hiatal hernia > 5 cm
- Age < 18_years
- Preexisting esophageal stricture
- Gastric stricture < 2 cm in diameter
- Anti-coagulant medication
- Use of platelet inhibitors other than acetylsalicylic acid
Show all 14Show fewer
- Manometric indication of motility disorder
- Connective tissue diseases
- BMI > 35
- Liver cirrhosis
- Coronary heart disease
- Chronic obstructive pulmonary disease
- Other significant comorbidity
- Indication for long-term PPI use other than GERD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Gastroesophageal reflux disease (GERD) occurs when stomach acid repeatedly flows back into the tube connecting your mouth and stomach (esophagus). This backwash (acid reflux) can irritate the inner lining of the esophagus. This is a particular problem after surgery to reduce obesity called gastric sleeve resection.
The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation. The main questions it aims to answer are:
Read more
- Does the treatment affect gastroesophageal reflux assessed by measuring gastroesophageal reflux
- Does the treatment affect gastroesophageal reflux symptoms and ability to stop treatment with medication commonly used (proton pump inhibitors)
Participants (n=12) will be asked to undergo 24 h reflux examination and report symptoms of GERD. Suitable patients will be offered endoscopic treatment with band ligation of the inner lining of the lower esophagus and upper part of the stomach. The effects will be assessed three and six months after the procedure.
Read the detailed description
Gastroesophageal reflux disease (GERD) is very common after gastric sleeve resection and many patients are dependent on daily use of proton pump inhibitors (PPIs). The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation.
Patients (n=12) with GERD satisfying inclusion and exclusion criteria will be invited to participate and the degree of gastroesophageal reflux will be assessed before treatment, and three and six months after the procedure. The results of the trial will be used to plan a larger study.
- Conditions
- Gastro Esophageal Reflux Disease
- Being tested
- Endoscopic mucosal band ligation
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic mucosal band ligationOther
The mucosa in 3/4 of the circumference of the gastroesophageal junction and cardia will be treated with mucosal band ligation left in place. This will be done during upper endoscopy in sedation. It is the endoscopic procedure that is being investigated.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic mucosal band ligation | Experimental | All 12 patients with GERD will undergo the same procedure. Multiple rubber bands will be used to ligate mucosa in the gastroesophageal junction and cardia in 3/4 of the circumference. Receives: Other: Endoscopic mucosal band ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline esophageal 24 hour pH/impedance at 3 months
Esophageal pH/impedance will be measured by a catheter left in place for 24 hours
Measured: 3 months
Change from baseline esophageal 24 hour pH/impedance at 6 months
Esophageal pH/impedance will be measured by a catheter left in place for 24 hours
Measured: 6 months
Change from baseline symptoms of gastroesophageal reflux at 3 months
GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)
Measured: 3 months
Change from baseline symptoms of gastroesophageal reflux at 6 months
GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)
Measured: 6 months
Change from baseline in use of proton pump inhibitors (PPI) at 3 months
PPI use (number of days PPI was used during the period 7-14 days before the 3 months visit)
Measured: 3 months
Change from baseline in use of proton pump inhibitors (PPI) at 6 months
PPI use (number of days PPI was used during the period 7-14 days before the 6 months visit)
Measured: 6 months
Adverse events during the study period of 6 months
Adverse events or complications of the treatment will be registered during the study period
Measured: 6 months
Secondary outcomes (4)
Change from baseline in dysphagia at 3 months
Dysphagia assessed by Marks score. The minimum value is 0 (no dysphagia) and the maximum value is 6 (can not eat, which is the most severe symptom).
Measured: 3 months
Change from baseline in dysphagia at 6 months
Dysphagia assessed by Marks score. The minimum value is 0 (no dysphagia) and the maximum value is 6 (can not eat, which is the most severe symptom).
Measured: 6 months
Change from baseline in Hills flap valve at 3 months
The Hills flap valve assessed during endoscopy. Minimum value is 1 (good function) and the maximum value is 4 (poor function)
Measured: 3 months
Change from baseline in Hills flap valve at 6 months
The Hills flap valve assessed during endoscopy. Minimum value is 1 (good function) and the maximum value is 4 (poor function)
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 posted10 Jan 2023
- Study start1 Aug 2025
- Primary completion1 Jul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Patients with GERD will be examined at baseline and after three and six months. Variables of GERD will be compared between the three different time points.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnar Qvigstad, MD, PhD, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678491
- Sponsor's protocol ID
- 490996/2022
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to publish all relevant data from this small trial with the detail level permitted by the local approval. Further data sharing will not be planned for.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Treatment of Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT05678491
- Acronym / sponsor ID
- 490996/2022
- Conditions
- Gastro Esophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Jan 2023 (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.
Gastroesophageal reflux disease (GERD) occurs when stomach acid repeatedly flows back into the tube connecting your mouth and stomach (esophagus). This backwash (acid reflux) can irritate the inner lining of the esophagus. This is a particular problem after surgery to reduce obesity called gastric sleeve resection.
The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation. The main questions it aims to answer are:
- Does the treatment affect gastroesophageal reflux assessed by measuring gastroesophageal reflux
- Does the treatment affect gastroesophageal reflux symptoms and ability to stop treatment with medication commonly used (proton pump inhibitors)
Participants (n=12) will be asked to undergo 24 h reflux examination and report symptoms of GERD. Suitable patients will be offered endoscopic treatment with band ligation of the inner lining of the lower esophagus and upper part of the stomach. The effects will be assessed three and six months after the procedure.
Detailed description
Gastroesophageal reflux disease (GERD) is very common after gastric sleeve resection and many patients are dependent on daily use of proton pump inhibitors (PPIs). The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation.
Patients (n=12) with GERD satisfying inclusion and exclusion criteria will be invited to participate and the degree of gastroesophageal reflux will be assessed before treatment, and three and six months after the procedure. The results of the trial will be used to plan a larger study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with GERD will be examined at baseline and after three and six months. Variables of GERD will be compared between the three different time points.
| Arm | Type | Receives |
|---|---|---|
| Endoscopic mucosal band ligation | Experimental | Other: Endoscopic mucosal band ligationAll 12 patients with GERD will undergo the same procedure. Multiple rubber bands will be used to ligate mucosa in the gastroesophageal junction and cardia in 3/4 of the circumference. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previous gastric sleeve resection
- GERD. GERD must be diagnosed by either endoscopic esophagitis or esophageal pH measurement with DeMeester score > 14.72 and pH <4 more than 4% of a 24-h period and symptom association probability (SAP) > 95%
- Subjective insufficient symptom control with PPI therapy once daily or intolerance to PPI or desire to stop PPI treatment and therefore willingness to undergo endoscopic treatment.
Key exclusion criteria (14 listed)
- Hiatal hernia > 5 cm
- Age < 18_years
- Preexisting esophageal stricture
- Gastric stricture < 2 cm in diameter
- Anti-coagulant medication
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 |
|---|---|---|
| Endoscopic mucosal band ligationThe mucosa in 3/4 of the circumference of the gastroesophageal junction and cardia will be treated with mucosal band ligation left in place. This will be done during upper endoscopy in sedation. It is the endoscopic procedure that is being investigated. | Other | Endoscopic mucosal band ligation |
Primary outcome
Change from baseline esophageal 24 hour pH/impedance at 3 months
Time frame: 3 months
Esophageal pH/impedance will be measured by a catheter left in place for 24 hours
Change from baseline esophageal 24 hour pH/impedance at 6 months
Time frame: 6 months
Esophageal pH/impedance will be measured by a catheter left in place for 24 hours
Change from baseline symptoms of gastroesophageal reflux at 3 months
Time frame: 3 months
GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)
Change from baseline symptoms of gastroesophageal reflux at 6 months
Time frame: 6 months
GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)
Change from baseline in use of proton pump inhibitors (PPI) at 3 months
Time frame: 3 months
PPI use (number of days PPI was used during the period 7-14 days before the 3 months visit)
Change from baseline in use of proton pump inhibitors (PPI) at 6 months
Time frame: 6 months
PPI use (number of days PPI was used during the period 7-14 days before the 6 months visit)
Adverse events during the study period of 6 months
Time frame: 6 months
Adverse events or complications of the treatment will be registered during the study period
4 secondary outcomes
Change from baseline in dysphagia at 3 months
Time frame: 3 months
Change from baseline in dysphagia at 6 months
Time frame: 6 months
Change from baseline in Hills flap valve at 3 months
Time frame: 3 months
Change from baseline in Hills flap valve at 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. The plan is to publish all relevant data from this small trial with the detail level permitted by the local approval. Further data sharing will not be planned for.
Related trials for Gastro Esophageal Reflux Disease
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Enrolling by invitationObservational study
Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
Gastro Esophageal Reflux
Not yet recruitingPhase 4
PPI Dosing Per CYP2C19 Genotype
Gastroesophageal Reflux Disease With Esophagitis
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
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.
Gunnar Qvigstad, MD, PhD study director
St. Olavs 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 Endoscopic mucosal band ligation in people with Gastro Esophageal Reflux Disease, run by St. Olavs Hospital at 1 site in Norway.
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 14 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: enrolling by invitation, as of the sponsor's last update on 21 Oct 2026. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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 from baseline esophageal 24 hour pH/impedance at 3 months (time frame: 3 months). The study lists 7 primary outcomes in all. 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 21 Oct 2026.