NCT01766037

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 18, 2017

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

January 7, 2013

Results QC Date

July 13, 2016

Last Update Submit

January 23, 2020

Conditions

Obesity

Keywords

obesityobeseweight loss

Outcome Measures

Primary Outcomes (2)

  • Mean Percent Excess Weight Loss (%EWL)

    The first effectiveness co-primary endpoint is the mean percent excess weight loss (%EWL) at 52-weeks. The hypothesis for the first primary effectiveness endpoint is that the difference in the mean percent excess weight loss (%EWL) at 52-weeks for the Aspiration Therapy (AT) group and Control group is at least 10%. Percent EWL is defined as absolute weight loss divided by baseline excess weight and multiplied by 100. Excess weight is determined from ideal body weights based on a BMI=25 kg/m2.

    52 weeks

  • % of Subjects Who Achieve >25% EWL

    The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve \> 25% EWL.

    52 weeks

Secondary Outcomes (13)

  • Mean Percent Total Body Weight Loss

    52 weeks

  • Percent of Subjects With ≥10% Total Body Weight Loss

    52 weeks

  • Mean Percent Change in Serum Lipids

    52 weeks

  • Mean Percent Change in Blood Pressure

    52 weeks

  • Mean Change in Score for IWQOL Questionnaire

    52 weeks

  • +8 more secondary outcomes

Other Outcomes (1)

  • Safety Outcomes

    52 weeks

Study Arms (2)

Aspiration Therapy

EXPERIMENTAL

Aspiration Therapy and Lifestyle Therapy

Device: Aspiration Therapy (AspireAssist)Behavioral: Lifestyle Therapy

Lifestyle Therapy

ACTIVE COMPARATOR

Lifestyle Therapy only

Behavioral: Lifestyle Therapy

Interventions

Aspiration Therapy (AspireAssist)DEVICE

Use of the AspireAssist device in aspiration therapy

Also known as: AspireAssist Aspiration Therapy System
Aspiration Therapy
Lifestyle TherapyBEHAVIORAL

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

Also known as: Lifestyle Behavioral Therapy
Aspiration TherapyLifestyle Therapy

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Measured BMI of 35.0-55.0 kg/m2 at time of screening.
  • years of age (inclusive) at time of screening.
  • Failed attempt for a duration equal to 3-months at weight loss by alternative approaches (e.g. supervised or unsupervised diets, exercise, behavioral modification programs).
  • Stable weight (\<3% change in self-reported weight) over the previous 3 months at time of screening).
  • Women of childbearing potential must agree to use at least one form of birth control (prescription hormonal contraceptives, diaphragm, IUD, condoms with or without spermicide, or voluntary abstinence) from time of study enrollment through study exit.
  • Willing and able to provide informed consent in English and comply with the protocol.

You may not qualify if:

  • Previous abdominal surgery that significantly increases the medical risks of gastrostomy tube placement
  • Esophageal stricture, pseudo-obstruction, severe gastroparesis or gastric outlet obstruction, inflammatory bowel disease
  • History of refractory gastric ulcers
  • Ulcers, bleeding lesions, or tumors discovered during endoscopic examination.
  • History of radiation therapy to the chest or abdomen
  • Uncontrolled hypertension (blood pressure \>160/100).
  • Diabetes treated with insulin or sulfonylurea medications
  • Any change in diabetes medication in previous 3 months
  • Hemoglobin A1C \>9.5%
  • History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or NYHA (New York Heart Association) class III or IV heart failure (defined below):
  • Class III: patients with marked limitation of activity and who are comfortable only at rest Class IV: patients who should be at complete rest, confined to bed or chair and who have discomfort with any physical activity
  • Coagulation disorders (platelets \< 100,000, PT \> 2 seconds above control or INR \> 1.5)
  • Anemia (Hemoglobin \<11.0 g/dL in women and \<12.5 g/dL in men)
  • Liver enzymes (ALT and AST) ≥3.0 times the upper limit of normal
  • Thyroid Stimulating Hormone (TSH) \>1.5 x upper limit of normal at screening.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Dept VA San Diego Health Care System

San Diego, California, 92161, United States

Location

Howard University Center for Wellness and Weight Loss Surgery

Washington D.C., District of Columbia, 20060, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

St. Mary Medical Center

Langhorne, Pennsylvania, 19047, United States

Location

University of Pennsylvania Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, 19146, United States

Location

Related Links

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Results Point of Contact

Title
VP Regulatory & Quality
Organization
Aspire Bariatrics, Inc.
monica.ferrante@aspirebariatrics.com
484-200-1031

Study Officials

  • Christopher Thompson, MS, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 11, 2013

Study Start

November 13, 2012

Primary Completion

June 24, 2015

Study Completion

March 30, 2019

Last Updated

January 27, 2020

Results First Posted

January 18, 2017

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared.

Locations

US(10)