Phase 4
Completed N=303
Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band
Source: ClinicalTrials.gov NCT00543140 ↗Enrolled (actual)
303
Serious AEs
45.5%
Results posted
Mar 2016
Primary outcomePrimary: Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant. — 8.91 percentage of subjects — p=0.6919
Summary
The purpose of the study is to evaluate the long term safety of the Swedish Adjustable Gastric Band (SAGB) in subjects with an SAGB in place. Specifically it is designed to determine the re-operation rate (band revision, band replacement and explants resulting from serious adverse device-related event {SADE}) of gastric banding at 4 and 5 year post implant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant. |
8.91 | 0.6919 |
| SECONDARY Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant. |
-0.22 | — |
| SECONDARY Percent Change in Excess Body Weight at 5 Years Post-implant |
-35.6 | — |
| SECONDARY Change in SF-36 Health Survey Physical Component at 5 Years Post Implant |
8.1 | — |
| SECONDARY Change in SF-36 Health Survey Mental Component at 5 Years Post Implant |
1.1 | — |
Eligibility Criteria
CI-06-0001 Inclusion Criteria:
Subjects eligible to participate in this study must fulfill all of the following criteria:
- Able to comprehend, follow and give signed informed consent;
- Consented to, and participated in EES Protocol CI-02-0006 titled "A Single-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity";
- Currently have an SAGB implant in place;
- Able to commit to long-term follow-up; up to 5 years after SAGB implantation, including band adjustment visits; and
- Living within the contiguous U.S.
CI-07-0006 Inclusion Criteria:
Subjects eligible to participate in this study must fulfill all of the following criteria:
- Able to comprehend, follow and give informed consent;
- 18 to 60 years of age (inclusive);
- Body Mass Index (BMI) of > 40 kg/m2 and £ 55 kg/m2, or BMI ³ 35 kg/m2 and < 40 kg/m2 with one or more co-morbid conditions.
- Candidate for surgical weight loss intervention in accordance with the Instructions For Use (i.e., meets acceptable health criteria for major surgery).
CI-06-0001 Exclusion Criteria:
Subjects with the following are not eligible to participate in this clinical trial and must not be enrolled in this study:
a. Consented to, and participated in EES Protocol CI-02-0006 titled "A aSingle-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity"; and have had the SAGB explanted.
CI-07-0006 Exclusion Criteria:
- Women who are currently pregnant.
- Previous malabsorptive or restrictive procedures performed for the treatment of morbid obesity.
- Documented history of drug and/or alcohol abuse within 2 years of the Screening Visit (1a).
- Presence of any of the following medical conditions;
- Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease;
- Severe cardiopulmonary disease or other serious organic disease;
- Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases;
- Portal hypertension;
- Anomalies of the gastrointestinal tract such as atresia or stenosis;
- Cirrhosis of the liver;
- Chronic pancreatitis;
- Patients on chronic, long-term steroid treatment or steroids within 15 days of surgery;
- Unable or unwilling to comply with dietary restrictions required by this procedure;
- Known allergy to materials contained within the band or its injection port (silicone elastomer containing 10% BaSO4, polyetheretherketone (PEEK), and cobalt chromium)
- Presence of terminal illness with life expectancy of £ 5 years.
- Inability to refrain from use of anticoagulants or aspirin within 15 days prior to surgery.
- Acute or chronic infection (localized or systemic).
- Participation in another clinical trial within 8 weeks of the Screening Visit (1a) and for the duration of this trial.
- Any medical condition or finding for which the Investigator utilizes their medical discretion to determine the subject should be excluded due to inability to understand or follow study procedures.
Data sourced from ClinicalTrials.gov (NCT00543140). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.