Trial Outcomes & Findings for EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity (NCT NCT02880189)
NCT ID: NCT02880189
Last Updated: 2022-06-15
Results Overview
Total number of subjects with two points or greater improvement on objective Non-alcoholic Steatohepatitis (NASH) histopathological parameters. The NAS scale can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline to 6 months post-procedure
Results posted on
2022-06-15
Participant Flow
Participant milestones
| Measure |
Single
All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.
Orbera Intragastric Balloon: 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.
Endoscopic Ultrasound Guided Core Liver Biopsy
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Single
n=21 Participants
All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.
Orbera Intragastric Balloon: 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.
Endoscopic Ultrasound Guided Core Liver Biopsy
|
|---|---|
|
Age, Continuous
|
54 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=21 Participants
|
|
Body Mass Index
|
44 kg/m^2
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 months post-procedureTotal number of subjects with two points or greater improvement on objective Non-alcoholic Steatohepatitis (NASH) histopathological parameters. The NAS scale can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2).
Outcome measures
| Measure |
Single
n=21 Participants
All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.
Orbera Intragastric Balloon: 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.
Endoscopic Ultrasound Guided Core Liver Biopsy
|
|---|---|
|
Weight Loss Achieved With Intragastric Balloon (IGB)
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-procedureTotal number of subjects correctly diagnosed with NASH and Early Fibrosis by EUS guided core liver biopsies
Outcome measures
| Measure |
Single
n=21 Participants
All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.
Orbera Intragastric Balloon: 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.
Endoscopic Ultrasound Guided Core Liver Biopsy
|
|---|---|
|
Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies
|
21 Participants
|
Adverse Events
Single
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single
n=21 participants at risk
All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.
Orbera Intragastric Balloon: 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.
Endoscopic Ultrasound Guided Core Liver Biopsy
|
|---|---|
|
Gastrointestinal disorders
Epigastric pain
|
14.3%
3/21 • Number of events 3 • The study treatment follow-up period was defined from enrollment in the study to 6 months after balloon removal.
|
|
General disorders
Laryngospasm
|
4.8%
1/21 • Number of events 1 • The study treatment follow-up period was defined from enrollment in the study to 6 months after balloon removal.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.8%
1/21 • Number of events 1 • The study treatment follow-up period was defined from enrollment in the study to 6 months after balloon removal.
|
|
Cardiac disorders
Non-ST-elevation myocardial infarction (NSTEMI)
|
4.8%
1/21 • Number of events 1 • The study treatment follow-up period was defined from enrollment in the study to 6 months after balloon removal.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place