Obesity, MorbidBiFLuxNCT04422405
Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB
A study testing One Anastomosis Gastric Bypass (OAGB) in people with Obesity, Morbid and GERD, run by Spital Limmattal Schlieren at 1 site in Switzerland.
Trial summary
Evaluation of the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid, GERD, Ulcer, Gastric
- What is being tested?
- One Anastomosis Gastric Bypass (OAGB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2020to 28 May 2035
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI> 35 kg/m2
- 2 years of controlled conservative obesity treatment without weight reduction
- patients should give their consent to participate in the study
Who cannot join
- Less than 2 years of conservative obesity treatment
- cancer
- cirrhosis Child-Pough score A
- Crohn's disease
- serious psychiatric disorder, which led to in-hospital treatment in psychiatric clinic in the past two years
- drug consumption
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Limmattal Hospital
Schlieren, Canton of Zurich, 8952
Urs Zingg, Prof., +41 44 733 21 26, urs.zingg@spital-limmattal.ch
About this study
Official title: Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial
Evaluation of the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB)
- Conditions
- Obesity, Morbid, GERD, Ulcer, Gastric
- Being tested
- One Anastomosis Gastric Bypass (OAGB)
- Medical subject headings
- Obesity, Morbid, Gastroesophageal Reflux, Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Anastomosis Gastric Bypass (OAGB)Procedure or surgery
Also called Mini-Gastric Bypass
The procedure is performed laparoscopically. The "GIA" stapler divides the stomach at the junction of the body and antrum. An Ewald tube, roughly the diameter of the esophagus, is passed by the anesthetist and held against the lesser curvature. The division of the stomach against the tube is completed, with 5- 6 lines of staples. The division of the stomach is parallel to the lesser curvature and up to the angle of His. A point is selected on the small bowel about 200 cm distal to the ligament of Treitz. The jejunal loop is brought up antecolic, and the Endo-GIA stapler is used to perform the anastomosis between the stomach and the small bowel at this point. The distal end of the gastric tube is anastomosed to the side of the small bowel.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing OAGB | Experimental | Not described Receives: Procedure: One Anastomosis Gastric Bypass (OAGB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal ulcer rates
Measured: 2 years post surgery
Marginal ulcer rates
Measured: 5 years post surgery
Assessment of age as risk factor for marginal ulcer development
Age of participants will be measured in years.
Measured: 2 years post surgery
Assessment of age as risk factor for marginal ulcer development
Age of participants will be measured in years
Measured: 5 years post surgery
Assessment of gender as risk factor for marginal ulcer development
The association between gender of participants (male/female) and incidence of marginal ulcers will be assessed.
Measured: 2 years post surgery
Assessment of gender as risk factor for marginal ulcer development
The association between gender of participants (male/female) and incidende of marginal ulcers will be assessed.
Measured: 5 years post surgery
Assessment of tobacco use as risk factor for marginal ulcer development
It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.
Measured: 2 years post surgery
Assessment of tobacco use as risk factor for marginal ulcer development
It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.
Measured: 5 years post surgery
Assessment of alcohol use as risk factor for marginal ulcer development
It will be assessed if the number of participants who report alcohol use correlates with the incidence of marginal ulcers.
Measured: 2 years post surgery
Assessment of alcohol use as risk factor for marginal ulcer development
It will be assessed if the the number of participants who report alcohol use correlates with the incidence of marginal ulcers.
Measured: 5 years post surgery
Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development
It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers.
Measured: 2 years post surgery
Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development
It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers.
Measured: 5 years post surgery
Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development
It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers.
Measured: 2 years post surgery
Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development
It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers.
Measured: 5 years post surgery
Assessment of Helicobacter pylori as risk factor for marginal ulcer development
It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcers.
Measured: 2 years post surgery
Assessment of Helicobacter pylori as risk factor for marginal ulcer development
It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcer.
Measured: 5 years post surgery
Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development
It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.
Measured: 2 years post surgery
Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development
It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.
Measured: 5 years post surgery
Assessment of diabetes mellitus as risk factor for marginal ulcer development
It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.
Measured: 2 years post surgery
Assessment of diabetes mellitus as risk factor for marginal ulcer development
It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.
Measured: 5 years post surgery
Assessment of dyslipidemia as risk factor for marginal ulcer development
It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers.
Measured: 2 years post surgery
Assessment of dyslipidemia as risk factor for marginal ulcer development
It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers.
Measured: 5 years post surgery
Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development
It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers.
Measured: 2 years post surgery
Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development
It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers.
Measured: 5 years post surgery
Secondary outcomes (28)
Total weight loss % (TWL)
Measured: 2 years post surgery
Total weight loss % (TWL)
Measured: 5 years post surgery
Excess weight loss % (EWL)
Measured: 2 years post surgery
Excess weight loss % (EWL)
Measured: 5 years post surgery
Total BMI loss (TBL)
Measured: 2 years post surgery
Total BMI loss (TBL)
Measured: 5 years post surgery
Excess BMI loss (EBL)
Measured: 2 years post surgery
Excess BMI loss (EBL)
Measured: 5 years post surgery
Late morbidity (>30 days)
Number of surgical complications according to Dindo-Clavien classification
Measured: 30 days post surgery
Late morbidity (>30 days)
Number of surgical complications according to Dindo-Clavien classification
Measured: 5 years
Incidence of gastroesopagheal reflux disease (GERD)
based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification
Measured: 2 years post surgery
Incidence of gastroesopagheal reflux disease (GERD)
based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification
Measured: 5 years post surgery
Incidence of Barrett's esophagus
based on biopsy findings
Measured: 2 years post surgery
Incidence of Barrett's esophagus
based on biopsy findings
Measured: 5 years post surgery
Changes of esophageal motor function
The esophageal motor function will be measured in mmHg via high-resolution manometry.
Measured: 2 years post surgery
Changes of esophageal motor function
The esophageal motor function will be measured in mmHg via high-resolution manometry.
Measured: 5 years post surgery
Esophageal acid or bolus exposure
Measured with impedance-pH Monitoring. Acid exposure (%) is defined as the total time the pH is < 4 divided by the time monitored. Bolus exposure (%) is defined as being analogous to acid exposure by adding the duration of all four reflux subcategories defined by the impedance, and dividing this value by the time monitored.
Measured: 2 years post surgery
Esophageal acid or bolus exposure
Measured with impedance-pH Monitoring. Acid exposure (%) is defined as the total time the pH is < 4 divided by the time monitored. Bolus exposure (%) is defined as being analogous to acid exposure by adding the duration of all four reflux subcategories defined by the impedance, and dividing this value by the time monitored.
Measured: 5 years post surgery
Number of acid or alcaline reflux events
Measured with impedance-pH Monitoring.
Measured: 2 years post surgery
Number of acid or alcaline reflux events
Measured with impedance-pH Monitoring.
Measured: 5 years post surgery
Gastrointestinal quality of life (QoL): GIQLI
The gastrointestinal (QoL) will be measured using the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a validated tool to assess health- related quality of life of patients with gastrointestinal disease or patients who undergo gastrointestinal operations. Its scale is 0-128. Higher values indicate a better quality of life outcome.
Measured: 2 years post surgery
Gastrointestinal quality of life (QoL): GIQLI
The gastrointestinal (QoL) will be measured using the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a validated tool to assess health- related quality of life of patients with gastrointestinal disease or patients who undergo gastrointestinal operations. Its scale is 0-128. Higher values indicate a better quality of life outcome.
Measured: 5 years post surgery
Obesity- related quality of life (QoL): BAROS
Obesity- related QoL will be measured with the BAROS (Bariatric Analysis and Reporting Outcome System). BAROS consists of a scoring table that includes three columns with the main areas of interest: weight loss, improvement of medical conditions, and QoL. A maximum of three points is given in each domain to evaluate changes after medical intervention (maximum score is 9 points). Higher scores indicate a better outcome.
Measured: 2 years post surgery
Obesity- related quality of life: BAROS
Obesity- related QoL will be measured with the BAROS (Bariatric Analysis and Reporting Outcome System). BAROS consists of a scoring table that includes three columns with the main areas of interest: weight loss, improvement of medical conditions, and QoL. A maximum of three points is given in each domain to evaluate changes after medical intervention (maximum score is 9 points). Higher scores indicate a better outcome.
Measured: 5 years post surgery
Reflux-associated symptoms
GERD symptoms will be measured with the Gastroesophageal reflux disease questionnaire (GERDQ). GERDQ has a scale between 0 and 18 points. Increasing scores correlate with increasing severity of heartburn symptoms.
Measured: 2 years post surgery
Reflux-associated symptoms
GERD symptoms will be measured with the Gastroesophageal reflux disease questionnaire (GERDQ). GERDQ has a scale between 0 and 18 points. Increasing scores correlate with increasing severity of heartburn symptoms.
Measured: 5 years post surgery
Reflux-associated quality of life (QoL): GERD-HRQL
Reflux- associated QoL will be assessed with the Health-related QoL scale for GERD (GERD-HRQL). The scale has 11 items, which focus on heartburn symptoms, dysphagia, medication effects and the patient's present health condition. Each item is scored from 0 to 5, with a higher score indicating a better QoL.
Measured: 2 years post surgery
Reflux-associated quality of life (QoL): GERD-HRQL
Reflux- associated QoL will be assessed with the Health-related QoL scale for GERD (GERD-HRQL). The scale has 11 items, which focus on heartburn symptoms, dysphagia, medication effects and the patient's present health condition. Each item is scored from 0 to 5, with a higher score indicating a better QoL.
Measured: 5 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jun 2020
- Primary completion28 May 2035 (estimated)
- Study completion28 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spital Limmattal Schlieren
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marko Kraljevic, MD, Spital Limmattal Schlieren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422405
- Sponsor's protocol ID
- SLS-003
- Acronym
- BiFLux
- Status last verified
- Jun 2025
- First submitted
- 25 May 2020
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial
- ClinicalTrials.gov ID
- NCT04422405
- Acronym / sponsor ID
- BiFLux / SLS-003
- Conditions
- Obesity, Morbid, GERD, Ulcer, Gastric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Spital Limmattal SchlierenUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 28 May 2035 (estimated)
- Study completion
- 28 May 2035 (estimated)
- First posted
- 9 Jun 2020 (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.
Evaluation of the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing OAGB | Experimental | Procedure: One Anastomosis Gastric Bypass (OAGB) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI> 35 kg/m2
- 2 years of controlled conservative obesity treatment without weight reduction
- patients should give their consent to participate in the study
Key exclusion criteria (16 listed)
- Less than 2 years of conservative obesity treatment
- cancer
- cirrhosis Child-Pough score A
- Crohn's disease
- serious psychiatric disorder, which led to in-hospital treatment in psychiatric clinic in the past two years
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 |
|---|---|---|
| One Anastomosis Gastric Bypass (OAGB)Also: Mini-Gastric BypassThe procedure is performed laparoscopically. The "GIA" stapler divides the stomach at the junction of the body and antrum. An Ewald tube, roughly the diameter of the esophagus, is passed by the anesthetist and held against the lesser curvature. The division of the stomach against the tube is completed, with 5- 6 lines of staples. The division of the stomach is parallel to the lesser curvature and up to the angle of His. A point is selected on the small bowel about 200 cm distal to the ligament of Treitz. The jejunal loop is brought up antecolic, and the Endo-GIA stapler is used to perform the anastomosis between the stomach and the small bowel at this point. The distal end of the gastric tube is anastomosed to the side of the small bowel. | Procedure or surgery | Patients undergoing OAGB |
Primary outcome
Marginal ulcer rates
Time frame: 2 years post surgery
Marginal ulcer rates
Time frame: 5 years post surgery
Assessment of age as risk factor for marginal ulcer development
Time frame: 2 years post surgery
Age of participants will be measured in years.
Assessment of age as risk factor for marginal ulcer development
Time frame: 5 years post surgery
Age of participants will be measured in years
Assessment of gender as risk factor for marginal ulcer development
Time frame: 2 years post surgery
The association between gender of participants (male/female) and incidence of marginal ulcers will be assessed.
Assessment of gender as risk factor for marginal ulcer development
Time frame: 5 years post surgery
The association between gender of participants (male/female) and incidende of marginal ulcers will be assessed.
Assessment of tobacco use as risk factor for marginal ulcer development
Time frame: 2 years post surgery
It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.
Assessment of tobacco use as risk factor for marginal ulcer development
Time frame: 5 years post surgery
It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.
Assessment of alcohol use as risk factor for marginal ulcer development
Time frame: 2 years post surgery
It will be assessed if the number of participants who report alcohol use correlates with the incidence of marginal ulcers.
Assessment of alcohol use as risk factor for marginal ulcer development
Time frame: 5 years post surgery
It will be assessed if the the number of participants who report alcohol use correlates with the incidence of marginal ulcers.
Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development
Time frame: 2 years post surgery
It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers.
Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development
Time frame: 5 years post surgery
It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers.
Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development
Time frame: 2 years post surgery
It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers.
Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development
Time frame: 5 years post surgery
It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers.
Assessment of Helicobacter pylori as risk factor for marginal ulcer development
Time frame: 2 years post surgery
It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcers.
Assessment of Helicobacter pylori as risk factor for marginal ulcer development
Time frame: 5 years post surgery
It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcer.
Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development
Time frame: 2 years post surgery
It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.
Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development
Time frame: 5 years post surgery
It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.
Assessment of diabetes mellitus as risk factor for marginal ulcer development
Time frame: 2 years post surgery
It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.
Assessment of diabetes mellitus as risk factor for marginal ulcer development
Time frame: 5 years post surgery
It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.
Assessment of dyslipidemia as risk factor for marginal ulcer development
Time frame: 2 years post surgery
It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers.
Assessment of dyslipidemia as risk factor for marginal ulcer development
Time frame: 5 years post surgery
It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers.
Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development
Time frame: 2 years post surgery
It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers.
Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development
Time frame: 5 years post surgery
It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers.
28 secondary outcomes
Total weight loss % (TWL)
Time frame: 2 years post surgery
Total weight loss % (TWL)
Time frame: 5 years post surgery
Excess weight loss % (EWL)
Time frame: 2 years post surgery
Excess weight loss % (EWL)
Time frame: 5 years post surgery
Total BMI loss (TBL)
Time frame: 2 years post surgery
Total BMI loss (TBL)
Time frame: 5 years post surgery
Excess BMI loss (EBL)
Time frame: 2 years post surgery
Excess BMI loss (EBL)
Time frame: 5 years post surgery
Late morbidity (>30 days)
Time frame: 30 days post surgery
Late morbidity (>30 days)
Time frame: 5 years
Incidence of gastroesopagheal reflux disease (GERD)
Time frame: 2 years post surgery
Incidence of gastroesopagheal reflux disease (GERD)
Time frame: 5 years post surgery
Incidence of Barrett's esophagus
Time frame: 2 years post surgery
Incidence of Barrett's esophagus
Time frame: 5 years post surgery
Changes of esophageal motor function
Time frame: 2 years post surgery
Changes of esophageal motor function
Time frame: 5 years post surgery
Esophageal acid or bolus exposure
Time frame: 2 years post surgery
Esophageal acid or bolus exposure
Time frame: 5 years post surgery
Number of acid or alcaline reflux events
Time frame: 2 years post surgery
Number of acid or alcaline reflux events
Time frame: 5 years post surgery
Gastrointestinal quality of life (QoL): GIQLI
Time frame: 2 years post surgery
Gastrointestinal quality of life (QoL): GIQLI
Time frame: 5 years post surgery
Obesity- related quality of life (QoL): BAROS
Time frame: 2 years post surgery
Obesity- related quality of life: BAROS
Time frame: 5 years post surgery
Reflux-associated symptoms
Time frame: 2 years post surgery
Reflux-associated symptoms
Time frame: 5 years post surgery
Reflux-associated quality of life (QoL): GERD-HRQL
Time frame: 2 years post surgery
Reflux-associated quality of life (QoL): GERD-HRQL
Time frame: 5 years post surgery
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 6 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One Anastomosis Gastric Bypass (OAGB) in people with Obesity, Morbid and GERD, run by Spital Limmattal Schlieren at 1 site in Switzerland.
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 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: looking for participants now, as of the sponsor's last update on 6 Jun 2025. 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 Switzerland. 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?
Contact Urs Zingg, MD, Prof. (+41 44 733 21 26, urs.zingg@spital-limmattal.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal ulcer rates (time frame: 2 years post surgery). The study lists 24 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 6 Jun 2025.