Weight Loss study: Treatment group
Official title Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')
ClinicalTrials.gov ID: NCT07195708
What this study is testing
- What it's testing
- To demonstrate the safety and how well it works of Orbera365 in obese populations to support the registration of Orbera365.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The subject is diagnosed with obesity, and the body mass index (BMI) is ≥28 kg/m² and ≤50 kg/m².
- The subject is aged ≥18 years.
- Failed previous conservative weight loss alternatives (e.g., supervised diet, exercise, and behavior modification programs).
- Willing to avoid the use of medical devices, medications, or other substances for weight loss purposes during the study period.
- Willing to avoid the use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the study period, including aspirin, diclofenac, ibuprofen...
You likely can't join if
- Prior surgery involving the esophagus, stomach, and duodenum.
- Prior bariatric surgery or intragastric medical devices for weight loss.
- A large hiatal hernia of \> 5 cm or a hernia ≤ 5 cm associated with severe or intractable gastroesophageal reflux symptoms.
- Patients who have a history of gastrointestinal obstruction, adhesive peritonitis.
- Any active inflammatory or neoplastic disease of the gastrointestinal tract.
- Potential upper gastrointestinal bleeding disorders, such as esophageal or gastric varices, congenital or acquired intestinal capillary ectasia, or...
See the full eligibility criteria
Who can join
- The subject is diagnosed with obesity, and the body mass index (BMI) is ≥28 kg/m² and ≤50 kg/m².
- The subject is aged ≥18 years.
- Failed previous conservative weight loss alternatives (e.g., supervised diet, exercise, and behavior modification programs).
- Willing to avoid the use of medical devices, medications, or other substances for weight loss purposes during the study period.
- Willing to avoid the use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the study period, including aspirin, diclofenac, ibuprofen, naproxen, or other known gastric-irritating drugs.
- Able to take proton pump inhibitors (PPIs), antiemetics, and other medications as prescribed by the researcher.
- Capable of walking completely independently, with no severe chronic orthopedic diseases.
- Willing to undergo gastroscopy.
- Voluntarily participate in the trial, sign the informed consent form, and be willing to comply with study requirements, including follow-ups.
What rules you out
- Prior surgery involving the esophagus, stomach, and duodenum.
- Prior bariatric surgery or intragastric medical devices for weight loss.
- A large hiatal hernia of \> 5 cm or a hernia ≤ 5 cm associated with severe or intractable gastroesophageal reflux symptoms.
- Patients who have a history of gastrointestinal obstruction, adhesive peritonitis.
- Any active inflammatory or neoplastic disease of the gastrointestinal tract. among these, inflammatory diseases include esophagitis, gastric ulcer, duodenal ulcer, and specific types (e.g., Crohn's disease), while...
- Potential upper gastrointestinal bleeding disorders, such as esophageal or gastric varices, congenital or acquired intestinal capillary ectasia, or other congenital gastrointestinal abnormalities, such as atresia or...
- A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope that precludes the usage for Orbera365.
- Achalasia, symptoms suggestive of delayed gastric emptying, or presence of any other severe motility disorder that that may pose a safety risk during placement or removal of the device.
- Positive result in the Helicobacter pylori breath test (Patients who turn negative after regular treatment can participate in this clinical trial).
- History or symptoms of uncontrolled or unstable thyroid disease.
- Abnormal coagulation with an INR \> 1.5 that cannot be corrected (as judged by a physician) or requiring continuous full anticoagulant therapy, and/or the presence of any underlying disease associated with a high risk...
- Hepatic insufficiency or liver cirrhosis, including: acute liver failure, advanced liver cirrhosis with encephalopathy, muscle atrophy, and generalized edema.
- Anemia: For females, hemoglobin (Hgb) \< 110 g/L. for males, hemoglobin (Hgb) \< 120 g/L.
- Patients with known or suspected allergic reactions to the materials contained in Orbera365.
- Any other physical conditions that do not allow for elective endoscopy, such as poor overall health or a history and/or symptoms of severe kidney, liver, heart, and/or lung diseases.
- Patients who are unable or unwilling to take the prescribed proton pump inhibitor medications during the device placement period.
- Patients who are unwilling to avoid any reconstructive and/or plastic surgeries that may affect weight during the study period, such as mammoplasty and liposuction.
- Patients who are unwilling to participate in the established medical supervision diet and behavior modification program and undergo regular medical follow-ups.
- Patients who are receiving treatment with anticoagulants, antiplatelet drugs, immunosuppressants, non-steroidal anti-inflammatory drugs (NSAIDs), or other drugs known to irritate the gastroduodenal mucosa or reduce...
- Alcohol abuse and/or drug abuse.
- Evidence of untreated mental or eating disorders, such as major depressive disorder, schizophrenia, substance abuse, binge eating disorder, or bulimia nervosa.
- Poor overall health, presence of specific diseases, or situations that, in the judgment of the researcher during evaluation and/or device placement, may put the subject at significant risk, may confound the study...
- Pregnant, breastfeeding, or having the intention to become pregnant during the study period (for females of childbearing potential).
- Currently participating in a study of investigational drugs or devices, or having participated in such a study within 30 days before participating in this study.
The study team makes the final eligibility decision.
Where it is enrolling
- Shanghai, Shanghai Municipality, China
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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.