BridgeMD
New treatment option for Obesity
Official title Benefits of Endoscopic Bariatric Procedures
ClinicalTrials.gov ID: NCT05514288
What this study is testing
- What it's testing
- This 12-months long pilot study will include patients undergoing an endoscopic procedure (endoscopic sleeve gastroplasty [ESG] or transoral outlet reduction [TORe]) as clinically indicated, and subsequent follow up clinic visits for up to one year.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Patients who are considering undergoing EBT for weight loss
- Patients with a BMI \>30 kg/m2 (without obesity related comorbidities)
- Patients with a BMI \>27 kg/m2 (with obesity related comorbidities)
- Patients willing and able to comply with study requirements for follow-up
- Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight
You likely can't join if
- Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
- Esophageal, gastric or duodenal malignancy
- Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
- Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each...
- Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
- General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation at the discretion of the...
See the full eligibility criteria
- Patients who are considering undergoing EBT for weight loss
- Patients with a BMI \>30 kg/m2 (without obesity related comorbidities)
- Patients with a BMI \>27 kg/m2 (with obesity related comorbidities)
- Patients willing and able to comply with study requirements for follow-up
- Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight
- Individuals 18 years old or older are included
- Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
- Esophageal, gastric or duodenal malignancy
- Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
- Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
- Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
- General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation at the discretion of the investigator
- Pregnant or planning to become pregnant during period of study participation
- Patient refuses or is unable to provide written informed consent
- Prior surgical or endoscopic anti-reflux procedure
- Patients who are unwilling or unable to comply with the follow-up study schedule
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.