Use of the INAMED LAPBAND System to Reduce BMI's in Obese Renal Failure Patients

NCT00466882 | Withdrawn DMC

• 1 other identifier: INAMED
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the use of this Lap-Band system for the purpose of promoting weight loss in renal failure patients who do not qualify as transplant candidates because of excessive BMI's

Conditions

Renal Failure; Obesity

Keywords

obese; renal failure; renal transplant candidate; Hemodialysis BMI between 36 and 42

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  Assess weight loss after surgery

  2 years

Secondary Outcomes (1)

• Transplantation Success

  2 years

Study Arms (1)

Inamed Lap-Band System

The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.

Device: Inamed Lap-Band System

Interventions

Inamed Lap-Band System DEVICE

Patient's will be seen in the physician's office one week post surgery and once a month thereafter. The device can be gradually adjusted by the insertion of a needle into the port and saline is added or removed to inflate or deflate the LAPBAND. This can be conducted in the physician's office setting to enable the patient to lose 1-2 pounds per week over two years.

Inamed Lap-Band System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with renal failure that have BMI's above 35 that would be a candidate for renal transplant if their BMI were 35 or less

You may qualify if:

• or older
• Hemodialysis patient with BMI between 36 and 42

You may not qualify if:

• Patients undergoing peritoneal dialysis

Sponsors & Collaborators

• Summa Health System: lead

Study Sites (1)

Summa Health System

Akron, Ohio, 44304, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Obesity

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John Zografakis, MD

  Summa Health System

  PRINCIPAL INVESTIGATOR

• Tanamay Lal, MD

  Summa Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Study Record Dates

• First Submitted: April 26, 2007
• First Posted: April 27, 2007
• Study Start: October 17, 2005
• Primary Completion: November 1, 2010
• Study Completion: January 24, 2011
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

US (1)