ORBERA365 Post-Marketing Clinical Follow-up Study

NCT04362774 | Terminated

• 1 other identifier: OPTiMA365
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, multicenter, open-label, post-approval study of the safety and effectiveness of ORBERA36 as a 12-month adjunct to weight reduction for obese adults (BMI ≥ 27 kg/m2 and BMI ≤ 50 kg/m2) or for pre-surgical weight reduction in obese and super-obese adults (BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities).

Conditions

Obesity; Overweight

Keywords

ORBERA

Outcome Measures

Primary Outcomes (1)

• Early Removal Percent

  To demonstrate that the percentage of early removals for safety reasons (no including patient requests for removal related to achieving desired weight loss or inability to lose weight and have another procedure) is \< 17.5%

  12 months

Secondary Outcomes (6)

• Total Body Weight Loss (%TBWL) Responders

  12 months

• Adverse Events (AEs)

  12 months

• % Total Body Weight Loss (%TBWL)

  12 months

• % Excess Weight Loss (%EWL)

  12 months

• Body Mass Index (BMI)

  12 months

Interventions

ORBERA365 DEVICE

Behavioral modification program in conjunction with endoscopic placement of a single ORBERA365 Intragastric Balloon, filled with saline to an inflation volume between 400cc and 700cc with 2mL of Methylene blue (10mg/mL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese adults who had already consented to receive ORBERA365 and who meet the eligibility criteria for the study.

You may qualify if:

• Male and female adult subjects;
• BMI ≥ 27 kg/m2 and ≤ 50 kg/m2 if treatment is for temporary use for weight loss in subjects who failed to achieve and maintain weight loss with a supervised weight-control program;
• BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities, if treatment is for pre-surgical temporary use for weight loss in order to reduce surgical risk
• Be willing to commit to a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight loss maintenance;
• Be able to follow the requirements outlined in the protocol, including complying with the visit schedule;
• Be able to provide written informed consent;

You may not qualify if:

• Presence of more than one ORBERA365 System Balloon at the same time;
• Prior surgery of the esophagus, stomach, or duodenum;
• Has any inflammatory disease of the gastrointestinal (GI) tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease;
• Has any upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the GI tract such as atresias or stenosis;
• Has a large hiatal hernia or hernia \> 5 cm;
• Has 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;
• Has any other medical condition which would not permit elective endoscopy, such as poor general health or history and/or symptoms of severe renal, hepatic, cardiac, and/or pulmonary disease;
• Has serious or uncontrolled psychiatric illness or disorder that could compromise subject understanding of or compliance with follow-up visits and removal of the device;
• Alcoholism or drug addiction;
• Unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up;
• Taking a daily dose of aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants routinely and not under medical supervision;
• Females who are pregnant, nursing, or planning a pregnancy within the next year;
• Known to have, or suspected, allergy to materials contained in ORBERA365;
• Participation in previous (within 60 days of study day 1) or ongoing clinical trial or current or past usage (within 60 days of study day 1) of investigational drug or device, or any use of an intragastric balloon prior to this study;
• Genetically caused obesity;

Sponsors & Collaborators

• Apollo Endosurgery, Inc.: lead

Study Sites (1)

Obymed

Seville, 41018, Spain

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose L Naveira

  Apollo Endosurgery, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: February 23, 2021
• Primary Completion: February 21, 2023
• Study Completion: October 10, 2023
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)