Trial Outcomes & Findings for HERO Study: Helping Evaluate Reduction in Obesity (NCT NCT00953173)

NCT ID: NCT00953173

Last Updated: 2018-03-08

Results Overview

Percent of total body weight change.

• Recruitment status: COMPLETED
• Target enrollment: 671 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2018-03-08

Participant Flow

Participant milestones

Measure	LapBand Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption.
Overall Study STARTED	671
Overall Study COMPLETED	389
Overall Study NOT COMPLETED	282

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HERO Study: Helping Evaluate Reduction in Obesity

Baseline characteristics by cohort

Measure	LapBand n=652 Participants Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption.
Age, Customized 18-20 years	9 Participants n=5 Participants
Age, Customized 21-29 years	63 Participants n=5 Participants
Age, Customized 30-39 years	164 Participants n=5 Participants
Age, Customized 40-49 years	199 Participants n=5 Participants
Age, Customized 50-59 years	166 Participants n=5 Participants
Age, Customized 60+ years	51 Participants n=5 Participants
Sex: Female, Male Female	517 Participants n=5 Participants
Sex: Female, Male Male	135 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Patients who attended 5 year visit.

Percent of total body weight change.

Outcome measures

Measure	LapBand n=383 Participants Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption.
%TBWL	-18.0 % TBWL Standard Deviation 12.69

Adverse Events

LapBand

Serious events: 106 serious events

Other events: 402 other events

Deaths: 2 deaths

Serious adverse events

Measure	LapBand n=652 participants at risk Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption.
Gastrointestinal disorders Gastrointestinal Disorder	5.2% 34/652 • Number of events 35 • 5 Years
General disorders General disorders and administration site conditions	0.31% 2/652 • Number of events 2 • 5 Years
Hepatobiliary disorders Hepatobiliary disorder	0.15% 1/652 • Number of events 1 • 5 Years
Infections and infestations Infections	0.46% 3/652 • Number of events 3 • 5 Years
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	0.92% 6/652 • Number of events 6 • 5 Years
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.15% 1/652 • Number of events 1 • 5 Years
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	0.31% 2/652 • Number of events 2 • 5 Years
Cardiac disorders Cardiac disorders	1.4% 9/652 • Number of events 11 • 5 Years
Congenital, familial and genetic disorders congenital, familial and genetic disorders	0.15% 1/652 • Number of events 2 • 5 Years
Eye disorders Eye disorders	0.15% 1/652 • Number of events 1 • 5 Years
Gastrointestinal disorders Gastrointestinal disorders-unrelated to device or procedure	1.7% 11/652 • Number of events 12 • 5 Years
General disorders General disorders-unrelated to device or procedure	0.31% 2/652 • Number of events 2 • 5 Years
Hepatobiliary disorders Hepatobiliary disorders-unrelated to device or procedure	1.1% 7/652 • Number of events 7 • 5 Years
Infections and infestations infections and infestations-unrelated to device or procedure	1.2% 8/652 • Number of events 8 • 5 Years
Injury, poisoning and procedural complications Injury, poisoning and procedural complications-unrelated to device or procedure	0.77% 5/652 • Number of events 5 • 5 Years
Metabolism and nutrition disorders Metabolism and nutrition disorders-unrelated to device or procedure	0.46% 3/652 • Number of events 3 • 5 Years
Metabolism and nutrition disorders Musculoskeletal-unrelated to device or procedure	1.4% 9/652 • Number of events 10 • 5 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified-unrelated to device or procedure	1.8% 12/652 • Number of events 12 • 5 Years
Nervous system disorders Nervous system-unrelated to device or procedure	0.46% 3/652 • Number of events 3 • 5 Years
Pregnancy, puerperium and perinatal conditions Pregnancy, puerperium and perinatal-unrelated to device or procedure	0.46% 3/652 • Number of events 4 • 5 Years
Psychiatric disorders Psychiatric disorders-unrelated to device or procedure	0.15% 1/652 • Number of events 1 • 5 Years
Renal and urinary disorders Renal and urinary disorders-unrelated to device or procedure	0.31% 2/652 • Number of events 2 • 5 Years
Reproductive system and breast disorders Reproductive system and breast disorders-unrelated to device or procedure	0.31% 2/652 • Number of events 2 • 5 Years
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders-unrelated to device or procedure	0.61% 4/652 • Number of events 4 • 5 Years
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders-unrelated to device or procedure	0.15% 1/652 • Number of events 1 • 5 Years
Surgical and medical procedures Surgical and medical procedures-unrelated to device or procedure	0.31% 2/652 • Number of events 2 • 5 Years
Vascular disorders Vascular disorders-unrelated to device or procedure	0.31% 2/652 • Number of events 2 • 5 Years

Other adverse events

Measure	LapBand n=652 participants at risk Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption.
Gastrointestinal disorders Dysphagia	26.2% 171/652 • Number of events 277 • 5 Years
Gastrointestinal disorders gastric polapse	5.5% 36/652 • Number of events 43 • 5 Years
Gastrointestinal disorders Gastroesophageal reflux	26.8% 175/652 • Number of events 256 • 5 Years
Gastrointestinal disorders Vomiting	31.4% 205/652 • Number of events 410 • 5 Years
Injury, poisoning and procedural complications Pouch dilatation	6.3% 41/652 • Number of events 44 • 5 Years

Additional Information

Director of Clinical Affairs

Apollo Endosurgery Inc

Phone: 512-279-5157

Email: jose.naveira@apolloendo.com

Results disclosure agreements

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