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NCT04422405Recruiting

Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB

Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial

Source: ClinicalTrials.gov · Last updated 6 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Evaluation of the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB)

Status (registry)
Recruiting
Study type
Interventional
Enrollment
300 (estimated)
First submitted
25 May 2020
Start date
1 Jun 2020
Primary completion date
28 May 2035
Lead sponsor
Spital Limmattal Schlieren
Diseases
Obesity
NCT number
NCT04422405

What you commit to

  • Study type: Interventional
  • Planned participants: 300
  • From 1 Jun 2020 to the primary completion date, 28 May 2035
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • drug consumption

Other illness

  • cancer
  • Crohn's disease
  • serious psychiatric disorder, which led to in-hospital treatment in psychiatric clinic in the past two years

Other

  • Less than 2 years of conservative obesity treatment
  • cirrhosis Child-Pough score A
  • non-compliance
  • hiatal hernia \> 4cm
  • gastric pouch \< 10cm
  • Barett esophagus
  • erosive esophagitis Grade C or D according to the Los Angeles Classification
  • endoscopically proven gastric stricture
  • acid exposition time \> 6% (Lyon criteria)
  • reflux episodes\> 80 /24 hours (Lyon criteria)
  • insufficient low esophageal sphincter according to manometry findings
  • pathological findings in the impedance pH-metry (acid and non-acid reflux)

Who the study is looking for

  • BMI\> 35 kg/m2
  • 2 years of controlled conservative obesity treatment without weight reduction
  • patients should give their consent to participate in the study

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Limmattal Hospital
Coordinator of this site? Confirm its status
SchlierenSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.