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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02356614
Other study ID # Apollo-001
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 2015
Est. completion date March 8, 2018

Study information

Verified date March 2018
Source Apollo Endosurgery, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a post-approval, multicenter, prospective, non-randomized, open-label, clinical study to evaluate the safety and effectiveness of the LAP-BAND® AP System in a lower obese population (BMI ≥ 30 kg/m2 and < 40 kg/m2) with one or more obesity-related comorbidity up to 10 years after implantation.

The reason your study has been terminated is based on the availability of long-term safety and effectiveness data from the OSB Lead-HERo-002 study and published literature.


Description:

FDA post-approval study designed to collect prospective data in a real-world setting to evaluate long-term safety and effectiveness of the LAP BAND® System in patients with a BMI of ≥ 30 kg/m2 and < 40 kg/m2 and one or more comorbid conditions. The Apollo-001 Study is a prospective, 10 year, multicenter study of patients who have decide to undergo implantation of the LAP-BAND AP® system. Outcomes include device explants, changes in weight, comorbid condition status, device- and procedure-related AEs, and reoperations.

The LBMI study was part of the condition of approval (CoA) for the Lap-Band device. It was terminated because it was no longer required to fulfill the condition of approval for the device. Apollo was able to fulfill the condition of approval (CoA) for the Lap-Band device by using data from published literature and another recently completed study (OSB Lead-Hero-002 study) which had long-term safety and effectiveness data addressing the conditions of approval.


Recruitment information / eligibility

Status Terminated
Enrollment 325
Est. completion date March 8, 2018
Est. primary completion date March 8, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. LAP-BAND® System placed in a facility in the United States

2. BMI = 30 kg/m2 and < 40 kg/m2 prior to LAP-BAND® placement

3. Presence of 1 or more obesity-related comorbidities prior to LAP-BAND® placement

4. Aged 18 or older

Exclusion Criteria:

1. Prior bariatric surgery.

2. Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter patterns of care, use of medications or the outcomes under study.

3. Vulnerable patients or those unable to exercise free informed consent.

4. Inability to complete the questionnaires.

5. Patients who are addicted to alcohol and/or drugs.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Illinois Bariatric Center Champaign Illinois
United States Bariatric Institute of Greater Chicago Chicago Illinois
United States Center for Metabolic & Bariatric Surgery Cincinnati Ohio
United States Utah Lap Band and General Surgery Draper Utah
United States Surgical Associates Fountain Valley California
United States Louisville Surgical Associates Louisville Kentucky
United States Surgical Specialists of Louisiana Metairie Louisiana
United States New York University New York New York
United States OSF Saint Anthony Medical Center Rockford Illinois
United States Advanced Weight Loss Surgery Rockville Maryland
United States St. Alexius New Start Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Apollo Endosurgery, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Percent Reoperations, Esophageal Dilatation, esophageal dysmotility, and related adverse events Percentage of patients experiencing reoperations, esophageal dilatation, esophageal dysmotility, and other device-related and procedure-related adverse events observed over the study assessment period. 10 Years
Primary Percentage of Explants The primary objective is to assess the percentage of patients who experience an explant of the LAP BAND System within 5 years of implantation. 5 Years
Secondary Response to the LAP-BAND Secondary objectives include assessment of patients who respond to the LAP BAND® System at 5 years, where response is defined as achieving at least 7%Total Body Loss (TBL), assessment of prevalence of diabetes at 5 years, and assessment of changes in obesity-related comorbid conditions at 5 years. 5 Years
Secondary Diabetes Assessment of prevalence of diabetes at 5 years 5 Year
Secondary Obesity related Comorbidity Assessment of changes in obesity-related comorbid conditions at Year 5 5 Year
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