NCT05704348 Sleeve-pex: A Randomized Trial to Reduce Reflux After Sleeve Gastrectomy
| NCT ID | NCT05704348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helse Forde |
| Condition | Gastroesophageal Reflux |
| Study Type | INTERVENTIONAL |
| Enrollment | 550 participants |
| Start Date | 2023-09-04 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 550 participants in total. It began in 2023-09-04 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to test gastropexy as a measure to reduce reflux in morbidly obese patients being submitted to sleeve gastrectomy. The main questions it aims to answer are: Does gastropexy reduce reflux symptoms? Does gastropexy reduce objective evidence of reflux? Participants will be randomized to gastropexy or no gastropexy, and researchers will compare these groups to see if reflux (symptoms / objective evidence of) is different in the two groups.
Eligibility Criteria
Inclusion Criteria: * Patients planned for bariatric surgery with primary LSG Exclusion Criteria: * Age below 18 yrs * Use of ARM for other reasons than reflux * Previous antireflux surgery * Inability to comprehend and respon to patient related outcome (PRO) questionnaire
Contact & Investigator
Villy Vage, MD PhD
STUDY CHAIR
Helse Forde
Frequently Asked Questions
Who can join the NCT05704348 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastroesophageal Reflux. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05704348 currently recruiting?
Yes, NCT05704348 is actively recruiting participants. Contact the research team at villy.vage@helse-bergen.no for enrollment information.
Where is the NCT05704348 trial being conducted?
This trial is being conducted at Førde, Norway, Oslo, Norway, Volda, Norway, Voss, Norway.
Who is sponsoring the NCT05704348 clinical trial?
NCT05704348 is sponsored by Helse Forde. The principal investigator is Villy Vage, MD PhD at Helse Forde. The trial plans to enroll 550 participants.