Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates

NCT02556138 | Terminated Results FDA Device

• 1 other identifier: 15-003183
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the Orbera Intragastric Balloon is a safe and effective means for weight loss and improved metabolic disease in patients with cirrhosis requiring liver transplantation.

Conditions

Obesity; Liver Cirrhosis

Keywords

Intragastric Balloon; ORBERA Intragastric Balloon; Weight Loss; BMI >35

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With >= 15% Excess Body Weight Loss at 6 Months

  The percentage of excess weight loss (%EWL) is a common metric for reporting weight loss after bariatric surgery. The %EWL can vary depending on the definitions of ideal body weight (IBW) used and the preoperative weight.

  6 months

Secondary Outcomes (2)

• Mean Percentage of Total Body Weight Loss (%TBWL) After Balloon Removal

  6 months

• Mean Percentage of Excess Weight Loss (%EWL) After Balloon Removal

  6 months

Study Arms (1)

Orbera Intragastric Balloon

EXPERIMENTAL

All subjects will be receiving the ORBERA Intragastric Balloon

Device: ORBERA Intragastric Balloon

Interventions

ORBERA Intragastric Balloon DEVICE

The ORBERA Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.

Orbera Intragastric Balloon

Eligibility Criteria

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

You may qualify if:

• Adults with end-stage liver disease who are listed for liver transplant
• Have failed the non-invasive approach to weight loss to be actively listed for transplant (requiring 2 clinical return visits without weight loss of \>5 kg)
• Body Mass Index (BMI) \>35
• Negative pregnancy test for females who are able to get pregnant and are of child-bearing age

You may not qualify if:

• A previous history of gastric or bariatric surgery
• Current or recent (within 6 months) gastric or duodenal ulcers
• Moderate to severe Portal hypertension defined as portal gastropathy graded as \>= to moderate/severe, gastric varices, or esophageal varices graded \> = moderate/large (Patients with varices which have been obliterated may be included).
• Calculated Model of End-stage Liver Disease (MELD) score \>25 or childs score \>10
• The presence of more than one gastric balloon 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.
• A large hiatal hernia or \>5 cm hernia or ≤5 cm with associated 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 or any other severe motility disorder that may pose a safety risk during removal of the device.
• Gastric mass
• Severe coagulopathy
• Patients who are known to have or suspected to have an allergic reaction to materials contained in ORBERA.
• Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 6 months.
• Alcoholism or drug addiction
• Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity; Liver Cirrhosis; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Body Weight Changes

Limitations and Caveats

The study terminated early as unable to obtain a timely newly requested investigational device exemption (IDE).

Results Point of Contact

• Title: Dr. Kymberly Watt
• Organization: Mayo Clinic

Watt.Kymberly@mayo.edu

507-266-1686

Study Officials

• Kymberly Watt, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 22, 2015
• Study Start: September 1, 2015
• Primary Completion: November 3, 2016
• Study Completion: November 3, 2016
• Last Updated: January 30, 2018
• Results First Posted: January 30, 2018

Record last verified: 2018-01

Locations

US (1)