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Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study (PATHWAY)

This study is ongoing, but not recruiting participants.
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 4, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study

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

Primary Outcome Measures:
  • Mean Percent Excess Weight Loss (%EWL) [ Time Frame: 52 weeks ]
    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.

  • % of Subjects Who Achieve >25% EWL [ Time Frame: 52 weeks ]
    The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve > 25% EWL.


Secondary Outcome Measures:
  • Mean Percent Total Body Weight Loss [ Time Frame: 52 weeks ]
    i) Mean percent absolute weight loss in AT compared to Control group

  • Percent of Subjects With ≥10% Total Body Weight Loss [ Time Frame: 52 weeks ]
    ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group

  • Mean Percent Change in Serum Lipids [ Time Frame: 52 weeks ]
    iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group

  • Mean Percent Change in Blood Pressure [ Time Frame: 52 weeks ]
    iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group

  • Mean Change in Score for IWQOL Questionnaire [ Time Frame: 52 weeks ]

    v) "Impact of Weight on Quality of Life" (IWQOL) questionnaire total score

    Total score ranges from a minimum of 0 to a maximum of 100. Based on the algorithm developed by Crosby, et.al., patients' IWQOLLite total scores are considered to have shown meaningful improvement from baseline to one year if they increased between 7 and 12 points, depending upon baseline severity in comparison to the normative mean. Normative means for the IWQOL-Lite have been derived from a sample of 534 non-obese individuals who were not enrolled in any weight loss treatment program [238 women and 296 men with BMI's between 18.5 and 29.9]. The data presented is the mean change in total score. The AT group demonstrated a mean improvement (increase) in score of 16.3 points, the Control group a mean improvement (increase) of 11.7 points.


  • Mean Change in Hemoglobin A1C [ Time Frame: 52 weeks ]
    vi) change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline). Hemoglobin A1C is measured as DCCT%. The change in mean DCCT% from Baseline to Week 52 is reported for this secondary endpoint.

  • Procedural Success [ Time Frame: 52 weeks ]
    vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy

  • Change in Medication for Hypertension [ Time Frame: 52 weeks ]
    Percent change in the number of medications taken by subjects for hypertension

  • Change in Medications for Dyslipidemia [ Time Frame: 52 weeks ]
    Percent change in the number of medications taken by subjects for dyslipidemia

  • Change in Medications for Type 2 Diabetes [ Time Frame: 52 weeks ]
    Percent change in the number of medications taken by subjects for Type 2 Diabetes

  • Change in Number of Subjects on Hypertension Medication [ Time Frame: 52 weeks ]
    Percent change in the number of subjects on Hypertension medication

  • Change in Number of Subjects on Dyslipidemia Medications [ Time Frame: 52 weeks ]
    Percent change in the number of subjects on Dyslipidemia medications

  • Change in Number of Subjects on Diabetes Medication [ Time Frame: 52 weeks ]
    Percent change in the number of subjects on Diabetes medication


Other Outcome Measures:
  • Safety Outcomes [ Time Frame: 52 weeks ]
    The incidence of procedure-related, device-related, and therapy-related serious adverse events. Also, the development of adverse eating behaviors will be assessed.


Enrollment: 171
Study Start Date: November 2012
Estimated Study Completion Date: June 2019
Primary Completion Date: June 2015 (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 some of the food left in your stomach 20 minutes after your meal, which reduces 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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766037

Locations
United States, California
Dept VA San Diego Health Care System
San Diego, California, United States, 92161
United States, District of Columbia
Howard University Center for Wellness and Weight Loss Surgery
Washington, District of Columbia, United States, 20060
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Pennsylvania
St. Mary Medical Center
Langhorne, Pennsylvania, United States, 19047
University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States, 19146
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:
Responsible Party: Aspire Bariatrics, Inc.
ClinicalTrials.gov Identifier: NCT01766037     History of Changes
Other Study ID Numbers: P12-001V
Study First Received: January 7, 2013
Results First Received: July 13, 2016
Last Updated: January 4, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared.

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

ClinicalTrials.gov processed this record on September 19, 2017