Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study (PATHWAY)

This study is currently recruiting participants.
Verified January 2014 by Aspire Bariatrics, Inc.
Sponsor:
Collaborators:
Boston Medical Center
Brigham and Women's Hospital
Cornell University
Howard University
Mayo Clinic
Northwestern University
St. Mary Medical Center
San Diego Veterans Healthcare System
University of Pennsylvania
Washington University School of Medicine
Information provided by (Responsible Party):
Aspire Bariatrics, Inc.
ClinicalTrials.gov Identifier:
NCT01766037
First received: January 7, 2013
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Obesity
Device: Aspiration Therapy (AspireAssist)
Behavioral: Lifestyle Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study

Resource links provided by NLM:


Further study details as provided by Aspire Bariatrics, Inc.:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    The first effectiveness primary endpoint is the mean percent excess weight loss (%EWL) at 52-weeks.

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



Secondary Outcome Measures:
  • Weight Loss [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    i) Mean percent absolute weight loss in AT compared to Control group

  • Absolute Weight Loss [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group

  • Change in Serum Lipids [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group

  • Change in Blood Pressure [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group

  • Quality of Life [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    v) "Impact of Weight on Quality of Life" (IWQOL) questionnaire

  • Change in Mean Hemoglobin A1C [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    vi) change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline)

  • Procedural Success [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy


Other Outcome Measures:
  • Safety outcomes [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    The incidence of procedure-related, device-related, and therapy-related adverse events will be measured, as well as the incidence of device related, or unrelated, serious adverse events, including unanticipated adverse device effects. Also, the development of adverse eating behaviors will be assessed.


Estimated Enrollment: 175
Study Start Date: November 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aspiration Therapy
Aspiration Therapy and Lifestyle Therapy
Device: Aspiration Therapy (AspireAssist)
Use of the AspireAssist device in aspiration therapy
Other Name: AspireAssist Aspiration Therapy System
Behavioral: Lifestyle Therapy
Lifestyle therapy is a behavioral, diet and physical activity education program
Other Name: Lifestyle Behavioral Therapy
Active Comparator: Lifestyle Therapy
Lifestyle Therapy only
Behavioral: Lifestyle Therapy
Lifestyle therapy is a behavioral, diet and physical activity education program
Other Name: Lifestyle Behavioral Therapy

Detailed Description:

The Aspiration process works by "correcting" meal portions after eating by removing the food left in your stomach 20 minutes after your meal, reducing the number of calories absorbed by your body. This is done through a tube placed through the abdomen into the stomach with a small valve attached at the surface of your skin. An aspiration system will attach to that valve after each major meal of the day and allow you to remove a portion of that meal.

During this study you will also be provided with Lifestyle therapy which includes behavioral therapy, diet and physical activity education. This Lifestyle therapy will also be provided to the participants who do not receive the AspireAssist so that the two groups can be compared and the benefit of aspiration for weight loss can be determined.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Measured BMI of 35.0-55.0 kg/m2 at time of screening.
  2. 21- 65 years of age (inclusive) at time of screening.
  3. 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).
  4. Stable weight (<3% change in self-reported weight) over the previous 3 months at time of screening).
  5. 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.
  6. Willing and able to provide informed consent in English and comply with the protocol.

Exclusion Criteria:

  1. Previous abdominal surgery that significantly increases the medical risks of gastrostomy tube placement
  2. Esophageal stricture, pseudo-obstruction, severe gastroparesis or gastric outlet obstruction, inflammatory bowel disease
  3. History of refractory gastric ulcers
  4. Ulcers, bleeding lesions, or tumors discovered during endoscopic examination.
  5. History of radiation therapy to the chest or abdomen
  6. Uncontrolled hypertension (blood pressure >160/100).
  7. Diabetes treated with insulin or sulfonylurea medications
  8. Any change in diabetes medication in previous 3 months
  9. Hemoglobin A1C >9.5%
  10. 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

  11. Coagulation disorders (platelets < 100,000, PT > 2 seconds above control or INR > 1.5)
  12. Anemia (Hemoglobin <11.0 g/dL in women and <12.5 g/dL in men)
  13. Liver enzymes (ALT and AST) ≥3.0 times the upper limit of normal
  14. Thyroid Stimulating Hormone (TSH) >1.5 x upper limit of normal at screening.
  15. Osteoporosis (DEXA T-Score ≤ -2.5 standard deviations below normal peak values).
  16. History of fragility fractures (fractures resulting from a fall from a standing height or less, or presenting in the absence of obvious trauma)
  17. Pregnant or lactating
  18. Diagnosed Bulimia or diagnosed Binge Eating Disorder (using DSM IV criteria)
  19. Night Eating Syndrome (diagnosed by EDE)
  20. Serum potassium < 3.8 mEq/L
  21. Chronic abdominal pain that would potentially complicate the management of the device
  22. Taking a GLP-1 agonist < 6 months.
  23. Taking prescription or over-the-counter medications for weight loss in the last 3 months before screening, or planning to participate in a commercial weight loss program in the next 24 months.
  24. Taking medication once or more per week that causes weight gain (e.g. atypical antipsychotics, monoamine oxidase inhibitors, lithium, selected anticonvulsants, tamoxifen, glucocorticoids)
  25. Self- reported history of substance abuse in last 3 years.
  26. Malignancy in the last 5 years (except for non-melanoma skin cancer).
  27. Physical or mental disability, or psychological illness that could interfere with compliance with the therapy.
  28. At high risk of having a medical complication from the endoscopic procedure or Aspiration Therapy weight loss program for any reason, including poor general health or severe organ dysfunction, such as cirrhosis or renal dysfunction (GFR <60 mL/min/1.73 m2 at screening, calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766037

Locations
United States, California
Dept VA San Diego Health Care System Recruiting
San Diego, California, United States, 92161
Contact: Mandy Kenyon    760-521-0008      
Principal Investigator: Amir Zarrinpar, MD         
United States, District of Columbia
Howard University Center for Wellness and Weight Loss Surgery Recruiting
Washington, District of Columbia, United States, 20060
Contact: Monique Turner    202-865-1126      
Principal Investigator: Terrence M Fullum, MD, FACS         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Dragan Mackovic    312-503-6227      
Principal Investigator: Robert Kushner, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Michele Ryan    617-525-8266    mryan@partners.org   
Principal Investigator: Christopher Thompson, MD, MSc         
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Alissa Flaccavento    617-638-5906    Alissa.Flaccavento@bmc.org   
Principal Investigator: Caroline Apovian, MD,FACP,FACN         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tamera Roberson    507-255-8621      
Principal Investigator: Mike Jensen, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Nicole Wright    314-362-7816    nwright@DOM.wustl.edu   
Principal Investigator: Steven A Edmundowicz, MD         
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Mike Wadden    212-583-1000 ext 38      
Principal Investigator: Louis Aronne, MD         
United States, Pennsylvania
St. Mary Medical Center Recruiting
Langhorne, Pennsylvania, United States, 19047
Contact: Miki Haas    215-710-4510      
Contact: Marci Campbell    215-710-4510      
Principal Investigator: Alan B Schorr, DO,FAAIM         
University of Pennsylvania Center for Weight and Eating Disorders Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Nicole J    215-573-5675    njochym@mail.med.upenn.edu   
Principal Investigator: Anastassia Amaro, MD         
Sponsors and Collaborators
Aspire Bariatrics, Inc.
Boston Medical Center
Brigham and Women's Hospital
Cornell University
Howard University
Mayo Clinic
Northwestern University
St. Mary Medical Center
San Diego Veterans Healthcare System
University of Pennsylvania
Washington University School of Medicine
Investigators
Principal Investigator: Christopher Thompson, MS, MD Brigham and Women's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Aspire Bariatrics, Inc.
ClinicalTrials.gov Identifier: NCT01766037     History of Changes
Other Study ID Numbers: P12-001V
Study First Received: January 7, 2013
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aspire Bariatrics, Inc.:
obesity
obese
weight loss

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014