Trial Outcomes & Findings for A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C (NCT NCT00999661)

NCT ID: NCT00999661

Last Updated: 2014-02-07

Results Overview

Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.

• Recruitment status: COMPLETED
• Target enrollment: 231 participants
• Primary outcome timeframe: Baseline to 24 months
• Results posted on: 2014-02-07

Participant Flow

Subject recruitment began in November, 2009 at 7 surgical centers in the United States.

This was a longitudinal, single arm, observational, non-comparative study of clinical outcomes. Subjects were asked to consent to data collection to the study parameters from their study records.

Participant milestones

Measure	Realize Adjustable Gastric Band-C All subjects implanted with the Realize Gastric Band-C.
Overall Study STARTED	231
Overall Study COMPLETED	161
Overall Study NOT COMPLETED	70

Reasons for withdrawal

Measure	Realize Adjustable Gastric Band-C All subjects implanted with the Realize Gastric Band-C.
Overall Study Lost to Follow-up	59
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1
Overall Study Not meeting eligibility criteria	9

Baseline Characteristics

A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C

Baseline characteristics by cohort

Measure	Realize Adjustable Gastric Band-C n=231 Participants All subjects implanted with the Realize Gastric Band-C.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	214 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	46.4 years STANDARD_DEVIATION 12.05 • n=5 Participants
Sex: Female, Male Female	180 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Region of Enrollment United States	231 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 24 months

Population: Intent to Treat Population - All subjects implanted with gastric band and signing informed consent.

Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.

Outcome measures

Measure	Realize Adjustable Gastric Band-C n=231 Participants All subjects implanted with the Realize Gastric Band-C.
Percent Excess Weight Change From Baseline to 24 Months	39.8 percent of excess weight at baseline Standard Deviation 25.12

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: Intent to Treat Population

Percent excess weight change from baseline to 12 months was calculated as (the baseline weight minus the weight at 12 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.

Outcome measures

Measure	Realize Adjustable Gastric Band-C n=231 Participants All subjects implanted with the Realize Gastric Band-C.
% Excess Weight Change From Baseline to 12 Months	36.6 percent of excess weight at baseline Standard Deviation 19.79

SECONDARY outcome

Timeframe: Baseline to 24 months

Change in Body Mass Index from Baseline to 24 months with last observation carried forward. The calculation was performed as the Body Mass Index at 24 months minus the Body Mass Index at Baseline.

Outcome measures

Measure	Realize Adjustable Gastric Band-C n=231 Participants All subjects implanted with the Realize Gastric Band-C.
Change in Body Mass Index From Baseline to 24 Months	-7.97 kilograms per meters squared Standard Deviation 5.233

Adverse Events

Realize Adjustable Gastric Band-C

Serious events: 9 serious events

Other events: 200 other events

Deaths: 0 deaths

Serious adverse events

Measure	Realize Adjustable Gastric Band-C n=231 participants at risk All subjects implanted with the Realize Gastric Band-C.
Gastrointestinal disorders Dysphagia	0.43% 1/231
Gastrointestinal disorders Gastrointestinal obstruction	0.43% 1/231
Hepatobiliary disorders Cholelithiasis	0.43% 1/231
Injury, poisoning and procedural complications Device migration	0.43% 1/231
Injury, poisoning and procedural complications Incisional hernia	0.43% 1/231
Injury, poisoning and procedural complications Medical device complication	0.87% 2/231
Injury, poisoning and procedural complications Post procedural pulmonary embolism	0.43% 1/231
Investigations Oxygen saturation decreased	0.43% 1/231
Metabolism and nutrition disorders Dehydration	0.43% 1/231

Other adverse events

Measure	Realize Adjustable Gastric Band-C n=231 participants at risk All subjects implanted with the Realize Gastric Band-C.
Gastrointestinal disorders Abdominal pain	42.9% 99/231
Gastrointestinal disorders Vomiting	30.7% 71/231
Gastrointestinal disorders Gastrooesophageal reflux disease	21.6% 50/231
Gastrointestinal disorders Dysphagia	20.8% 48/231
Gastrointestinal disorders Nausea	16.0% 37/231
Injury, poisoning and procedural complications Procedural pain	14.3% 33/231
Gastrointestinal disorders Constipation	6.5% 15/231
General disorders Injection site pain	6.5% 15/231

Additional Information

Michael Schwiers, Principal Biostatistician

Ethicon Endo-Surgery, Inc.

Phone: 513-337-1172

Email: mschwier@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PIs agreed that the first publication of results should be made in conjunction with the presentation of a joint, multicenter publication of the results with the PIs from all sites contributing data, analyses, and comments. If this publication was not submitted within 12 months after conclusion of the Study at all sites, or after Sponsor confirmed there would be no multicenter Study publication, whichever is first, the PIs could have published the results from their individual sites.
• Publication restrictions are in place

Restriction type: OTHER