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

Morbid Obesity Clinical Trial

Official title:

A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C at 2 Years in a US Patient Population of Morbidly Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999661
• Other study ID #: CI-09-0007
• Status: Completed
• Phase: N/A
• First received: October 20, 2009
• Last updated: January 8, 2014
• Start date: November 2009
• Est. completion date: May 2012

Study information

• Verified date: January 2014
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the results patients are obtaining with the Realize™ Adjustable Gastric Band-C during the first 24 months after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Received an implant with the Realize Band-C according to the following indications for use:

1. Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions.

2. Male and female adult patients (adult is defined as 18 years of age or older)

3. Failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.

2. Able to comprehend, follow, and give signed informed consent.

Exclusion Criteria:

1. Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease;

2. Severe cardiopulmonary disease or other serious organic disease;

3. Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases;

4. Portal hypertension;

5. Anomalies of the gastrointestinal tract such as atresia or stenosis;

6. Cirrhosis of the liver;

7. Chronic pancreatitis;

8. Localized or systemic infection;

9. On chronic, long-term systemic steroid treatment or systemic steroids within 15 days of surgery;

10. Unable or unwilling to comply with dietary restrictions required by this procedure;

11. Known allergy to materials contained in the gastric band or its Injection Port;

12. Women who are pregnant;

13. Women at childbearing potential planning to get pregnant within 2 years or not using acceptable methods of contraception.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

References & Publications (2)

Cunneen SA, Brathwaite CE, Joyce C, Gersin K, Kim K, Schram JL, Wilson EB, Rodriguez CE, Gutierrez M. Clinical outcomes of the REALIZE adjustable gastric band-C at one year in a U.S. population. Surg Obes Relat Dis. 2012 May-Jun;8(3):288-95. doi: 10.1016/ — View Citation

Cunneen SA, Brathwaite CE, Joyce C, Gersin K, Kim K, Schram JL, Wilson EB, Schwiers M, Gutierrez M. Clinical outcomes of the Realize Adjustable Gastric Band-C at 2 years in a United States population. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):885-93. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Excess Weight Change From Baseline to 24 Months	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.	Baseline to 24 months	No
Secondary	% Excess Weight Change From Baseline to 12 Months	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.	Baseline to 12 months	No
Secondary	Change in Body Mass Index From 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.	Baseline to 24 months	No