Trial Outcomes & Findings for Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates (NCT NCT02556138)

NCT ID: NCT02556138

Last Updated: 2018-01-30

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-01-30

Participant Flow

All subjects were recruited at the Mayo Clinic in Rochester, Minnesota.

Participant milestones

Measure	Orbera Intragastric Balloon All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Orbera Intragastric Balloon All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Orbera Intragastric Balloon n=8 Participants All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
Age, Continuous	56 years STANDARD_DEVIATION 4.6 • n=8 Participants
Sex: Female, Male Female	1 Participants n=8 Participants
Sex: Female, Male Male	7 Participants n=8 Participants
Region of Enrollment United States	8 participants n=8 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intent to treat analysis

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.

Outcome measures

Measure	Orbera Intragastric Balloon n=8 Participants All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
Number of Subjects With >= 15% Excess Body Weight Loss at 6 Months	8 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Intent to treat analysis

%TBWL at 6 months = Number of kg lost at 6 months/starting weight in kg

Outcome measures

Measure	Orbera Intragastric Balloon n=8 Participants All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
Mean Percentage of Total Body Weight Loss (%TBWL) After Balloon Removal	12.3 percentage of weight loss Standard Deviation 8.1

SECONDARY outcome

Timeframe: 6 months

Population: Intent to treat analysis

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.

Outcome measures

Measure	Orbera Intragastric Balloon n=8 Participants All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
Mean Percentage of Excess Weight Loss (%EWL) After Balloon Removal	26.3 percentage of weight loss Standard Deviation 16.8

Adverse Events

Orbera Intragastric Balloon

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Orbera Intragastric Balloon n=8 participants at risk All subjects received the ORBERA Intragastric Balloon. The ORBERA Intragastric Balloon was placed in the stomach endoscopically through a catheter under conscious sedation. The procedure took about 20 minutes to complete. The balloon stayed in place for 6 months and then it was removed endoscopically.
Gastrointestinal disorders Balloon intolerance	12.5% 1/8 • Number of events 1 • 6 months
Hepatobiliary disorders Liver decompensation	25.0% 2/8 • Number of events 2 • 6 months
General disorders Mallory-Weiss tears	25.0% 2/8 • Number of events 2 • 6 months
Hepatobiliary disorders Hepatocellular carcinoma	25.0% 2/8 • Number of events 2 • 6 months
Gastrointestinal disorders Retching	25.0% 2/8 • Number of events 2 • 6 months

Additional Information

Dr. Kymberly Watt

Mayo Clinic

Phone: 507-266-1686

Email: Watt.Kymberly@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place