Safety and Effectiveness of Orbera365™ Intragastric Balloon System

Official title

Safety and Effectiveness of Orbera365™ Intragastric Balloon System: A Multi-Center, Prospective, Standard of Care Registry

Overview

This is a prospective, multi-center, standard of care registry offered to subjects in the EU only that have already agreed to receive the Orbera365™ Intragastric Balloon (IGB) System for weight loss. Subjects that agree to participate in the registry will have data reported associated with standard of care weight management visits during the time the device is implanted (in-dwell period), with an additional visit 30 days after the removal procedure.

Detailed description

The study's objective is to confirm the safety of the Orbera365™ Intragastric Balloon (IGB) for extended in situ dwell time (from 6 months up to 12 months). This information can be collected from standard-of-care data. Up to ten (10) sites located in Europe are planned to participate in this registry. A minimum of 100 subjects are required for the registry. A maximum of 200 subjects may be enrolled into the registry.

The study population will include Obese patients ((Body Mass Index (BMI) 30-50 kg/m2)) who have already consented to receive the Orbera365™ IGB System, who previously failed to achieve and maintain weight loss with a supervised weight-control program.

Study subjects will also include obese and super obese patients (BMI 40 kg/m2 and above or a BMI of 35 kg/m2 with comorbidities) prior to obesity or other surgery, in order to reduce surgical risk.

The duration of study participation is expected to be up to thirteen months from study placement procedure. The total treatment with the study device will be no more than 12 months from placement. A 30-day post-removal assessment will be performed following the study removal procedure. The subject will have completed the study upon the completion of the 30-day post-removal assessment, regardless of when the study removal procedure occurred.

Interventions

• Device Intragastric Balloon
  The Orbera365™ IGB System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight loss maintenance. The IGB is placed in the stomach and filled with sterile saline, causing it to expand into a spherical shape. The filled IGB is designed to occupy space and move freely within the stomach, potentially altering appetite and satiety to achieve weight loss.

Primary outcome measures

• Rate of Subjects with Serious Adverse Events [Time frame: Up to 12 months]
• Rate of Treatment Completers [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

• Subject is ≥ 18 years of age
• Subject meets the indicated population for the device according to the Instructions for Use (IFU) including obese patients with the BMI of 30-50 kg/m2 for weight loss and patients with BMI 40 kg/m2 and above or a BMI of 35 kg/m2 with comorbidities before obesity or another surgery, unless contraindicated.
• Subject is able to read, understand, and sign a written Informed Consent Form to participate in the registry

Exclusion criteria

• Subject is planning on becoming pregnant during the one year following study device placement
• Subject will complete follow-up visits at a location that the treating physician does not practice
• Subjects who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
• Current use or use within the three months before the baseline visit of over-the-counter or prescribed weight loss supplements/medications.
• Subjects who have conditions that are contraindicated for Orbera365™ IGB System as per the IFU, including, but not limited to:

• The presence of more than one IGB at the same time.
• Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease
• Potential upper gastrointestinal bleeding conditions
• A large hiatal hernia of > 5cm or a hernia ≤ 5 cm associated with severe or intractable gastro- esophageal reflux symptoms
• 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
• 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.
• Gastric Mass.
• Severe coagulopathy.
• Taking aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants and not under medical supervision.
• Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Spain · 2 centers

• EndoBes - Centre Medico Teknon — Barcelona
• Dorsia Clinic, Madrid Spain — Madrid

Czechia · 1 center

• OB Klinika — Prague

France · 1 center

• Hôpital Avicenne — Bobigny

United Kingdom · 1 center

• UHCW NHS Trust — Coventry

Identifiers

NCT: NCT07062094 · E7235

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗