Trial Outcomes & Findings for Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner (NCT NCT01372501)

NCT ID: NCT01372501

Last Updated: 2017-02-15

Results Overview

Excess weight was determined from ideal body weights based on a BMI of 25 kg/m2

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: 52 Weeks
• Results posted on: 2017-02-15

Participant Flow

Participant milestones

Measure	EndoBarrier Liner Device All patients will be implanted with the Endobarrier Liner device. Endobarrier Liner: Medical device placed endoscopically in the duodenum
Overall Study STARTED	19
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	EndoBarrier Liner Device All patients will be implanted with the Endobarrier Liner device. Endobarrier Liner: Medical device placed endoscopically in the duodenum
Overall Study Adverse Event	4
Overall Study Device migration	1

Baseline Characteristics

Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner

Baseline characteristics by cohort

Measure	EndoBarrier Liner Device n=19 Participants All patients will be implanted with the Endobarrier Liner device Endobarrier Liner: Medical device placed endoscopically in the duodenum
Age, Continuous	38.5 years STANDARD_DEVIATION 11.32 • n=5 Participants
Gender Female	15 Participants n=5 Participants
Gender Male	4 Participants n=5 Participants
Region of Enrollment Chile	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 52 Weeks

Population: Full Analysis Set (FAS) population had a device successfully implanted.

Excess weight was determined from ideal body weights based on a BMI of 25 kg/m2

Outcome measures

Measure	EndoBarrier Liner Device n=19 Participants All patients will be implanted with the Endobarrier Liner device Endobarrier Liner: Medical device placed endoscopically in the duodenum
Assessment of the % Excess Weight Loss at Week 52 or Last Assessment	26.9 %EWL Standard Deviation 20.35

SECONDARY outcome

Timeframe: Week 52

Population: Per Protocol Population (n=14); subjects who had the device implanted for 52 weeks.

Outcome measures

Measure	EndoBarrier Liner Device n=14 Participants All patients will be implanted with the Endobarrier Liner device Endobarrier Liner: Medical device placed endoscopically in the duodenum
Change in Absolute Weight Loss From Baseline to Week 52	-7.1 kg Standard Deviation 3.34

Adverse Events

EndoBarrier Liner Device

Serious events: 10 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	EndoBarrier Liner Device n=19 participants at risk All patients will be implanted with the Endobarrier Liner device Endobarrier Liner: Medical device placed endoscopically in the duodenum
Gastrointestinal disorders Gastrointestinal infection	5.3% 1/19 • Number of events 1 • 1.5 years
Gastrointestinal disorders Upper abdominal pain	21.1% 4/19 • Number of events 4 • 1.5 years
Gastrointestinal disorders Vomiting	5.3% 1/19 • Number of events 1 • 1.5 years
Gastrointestinal disorders Upper gastrointestinal bleeding	5.3% 1/19 • Number of events 1 • 1.5 years
Cardiac disorders Atrial fibrillation	5.3% 1/19 • Number of events 1 • 1.5 years
Cardiac disorders Tachycardia	5.3% 1/19 • Number of events 1 • 1.5 years
Injury, poisoning and procedural complications ankle fracture	5.3% 1/19 • Number of events 1 • 1.5 years

Other adverse events

Measure	EndoBarrier Liner Device n=19 participants at risk All patients will be implanted with the Endobarrier Liner device Endobarrier Liner: Medical device placed endoscopically in the duodenum
Gastrointestinal disorders Abdominal pain upper	57.9% 11/19 • Number of events 20 • 1.5 years
Gastrointestinal disorders Abdominal pain	36.8% 7/19 • Number of events 8 • 1.5 years
Gastrointestinal disorders Nausea	21.1% 4/19 • Number of events 4 • 1.5 years
General disorders Pyrexia	15.8% 3/19 • Number of events 3 • 1.5 years
Gastrointestinal disorders Vomiting	15.8% 3/19 • Number of events 4 • 1.5 years
Infections and infestations Gastroenteritis	15.8% 3/19 • Number of events 3 • 1.5 years
Infections and infestations Bronchitis	10.5% 2/19 • Number of events 2 • 1.5 years
Injury, poisoning and procedural complications Procedural nausea	52.6% 10/19 • Number of events 11 • 1.5 years
Injury, poisoning and procedural complications Procedural vomiting	42.1% 8/19 • Number of events 10 • 1.5 years
Nervous system disorders Headache	15.8% 3/19 • Number of events 3 • 1.5 years
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	10.5% 2/19 • Number of events 2 • 1.5 years

Additional Information

Clinical Affairs Manager

GI Dynamics, Inc.

Phone: 781.357.3261

Email: pkeating@gidynamics.com

Results disclosure agreements

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