Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study

Summary

This research study is being performed to find out if a new device, AspireAssist Aspiration Therapy System, can help people with obesity to lose weight without causing too many side effects.

Conditions

• Obesity

Interventions

DEVICE

Aspiration Therapy (AspireAssist)

Use of the AspireAssist device in aspiration therapy

BEHAVIORAL

Lifestyle Therapy

Lifestyle therapy is a behavioral, diet and physical activity education program

Sponsors & Collaborators

• Boston Medical Center

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Cornell University

  collaborator OTHER

• Howard University

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• St. Mary's Medical Center

  collaborator OTHER

• San Diego Veterans Healthcare System

  collaborator FED

• University of Pennsylvania

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Aspire Bariatrics, Inc.

  lead INDUSTRY

Principal Investigators

• Christopher Thompson, MS, MD · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-11-13

Primary Completion

2015-06-24

Completion

2019-03-30

Countries

• United States

Study Locations