NCT05678491|Enrolling By Invitation
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Sponsor study identifier
interventional
12
1 country
1
Study Start
August 1, 2025
Actual (reported)Primary Completion
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2023
Actual (reported)January 10, 2023
Actual (reported)August 1, 2025
Actual (reported)July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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)
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)
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)
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)
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
6 months
Change from baseline in dysphagia at 3 months
3 months
Change from baseline in dysphagia at 6 months
6 months
Change from baseline in Hills flap valve at 3 months
3 months
Change from baseline in Hills flap valve at 6 months
6 months
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
St.Olavs Hospital
Trondheim, 7030, Norway
Gunnar Qvigstad, MD, PhD
St. Olavs Hospital
First Submitted
January 2, 2023
First Posted
January 10, 2023
Study Start
August 1, 2025
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
July 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 21, 2026
Record last verified: 2026-10
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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