ObesityPATHWAYNCT01766037
Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study
A study testing Aspiration Therapy (AspireAssist) and Lifestyle Therapy in people with Obesity, run by Aspire Bariatrics, Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Aspiration Therapy (AspireAssist) and Lifestyle Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 10 sitesUnited States
- Study dates
- 13 Nov 2012to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Measured BMI of 35.0-55.0 kg/m2 at time of screening.
- 21- 65 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.
Who cannot join
- 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).
Show all 29Show fewer
- 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.
- Osteoporosis (DEXA T-Score ≤ -2.5 standard deviations below normal peak values).
- History of fragility fractures (fractures resulting from a fall from a standing height or less, or presenting in the absence of obvious trauma)
- Pregnant or lactating
- Diagnosed Bulimia or diagnosed Binge Eating Disorder (using DSM IV criteria)
- Night Eating Syndrome (diagnosed by EDE)
- Serum potassium < 3.8 mEq/L
- Chronic abdominal pain that would potentially complicate the management of the device
- Taking a GLP-1 agonist < 6 months.
- 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.
- Taking medication once or more per week that causes weight gain (e.g. atypical antipsychotics, monoamine oxidase inhibitors, lithium, selected anticonvulsants, tamoxifen, glucocorticoids)
- Self- reported history of substance abuse in last 3 years.
- Malignancy in the last 5 years (except for non-melanoma skin cancer).
- Physical or mental disability, or psychological illness that could interfere with compliance with the therapy.
- 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).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
Northwestern University
Chicago, Illinois, 60611
St. Mary Medical Center
Langhorne, Pennsylvania, 19047
Weill Cornell Medical College
New York, New York, 10065
University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 19146
Mayo Clinic
Rochester, Minnesota, 55905
Dept VA San Diego Health Care System
San Diego, California, 92161
Washington University School of Medicine
St Louis, Missouri, 63110
Howard University Center for Wellness and Weight Loss Surgery
Washington D.C., District of Columbia, 20060
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Aspiration Therapy (AspireAssist), Lifestyle Therapy
- Keywords
- obesity, obese, weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration Therapy (AspireAssist)Device
Also called AspireAssist Aspiration Therapy System
Use of the AspireAssist device in aspiration therapy
Lifestyle TherapyBehavioural
Also called Lifestyle Behavioral Therapy
Lifestyle therapy is a behavioral, diet and physical activity education program
| Study group | Role | What they receive |
|---|---|---|
| Aspiration Therapy | Experimental | Aspiration Therapy and Lifestyle Therapy Receives: Device: Aspiration Therapy (AspireAssist); Behavioral: Lifestyle Therapy |
| Lifestyle Therapy | Active comparator | Lifestyle Therapy only Receives: Behavioral: Lifestyle Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 52 weeks
Secondary outcomes (13)
Mean Percent Total Body Weight Loss
- Mean percent absolute weight loss in AT compared to Control group
Measured: 52 weeks
Percent of Subjects With ≥10% Total Body Weight Loss
ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group
Measured: 52 weeks
Mean Percent Change in Serum Lipids
iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group
Measured: 52 weeks
Mean Percent Change in Blood Pressure
iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group
Measured: 52 weeks
Mean Change in Score for IWQOL Questionnaire
- "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.
Measured: 52 weeks
Mean Change in Hemoglobin A1C
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.
Measured: 52 weeks
Procedural Success
vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy
Measured: 52 weeks
Change in Medication for Hypertension
Percent change in the number of medications taken by subjects for hypertension
Measured: 52 weeks
Change in Medications for Dyslipidemia
Percent change in the number of medications taken by subjects for dyslipidemia
Measured: 52 weeks
Change in Medications for Type 2 Diabetes
Percent change in the number of medications taken by subjects for Type 2 Diabetes
Measured: 52 weeks
Change in Number of Subjects on Hypertension Medication
Percent change in the number of subjects on Hypertension medication
Measured: 52 weeks
Change in Number of Subjects on Dyslipidemia Medications
Percent change in the number of subjects on Dyslipidemia medications
Measured: 52 weeks
Change in Number of Subjects on Diabetes Medication
Percent change in the number of subjects on Diabetes medication
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study start13 Nov 2012
- Primary completion24 Jun 2015
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspire Bariatrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Medical Center, Brigham and Women's Hospital, Cornell University, Howard University, Mayo Clinic, Northwestern University, St. Mary's Medical Center, San Diego Veterans Healthcare System, University of Pennsylvania, Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Christopher Thompson, MS, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766037
- Sponsor's protocol ID
- P12-001V
- Acronym
- PATHWAY
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2013
- Last updated
- 27 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study
- ClinicalTrials.gov ID
- NCT01766037
- Acronym / sponsor ID
- PATHWAY / P12-001V
- Conditions
- Obesity
- Keywords
- obesity, obese, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Aspire Bariatrics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Boston Medical Center, Brigham and Women's Hospital, Cornell University, Howard University, Mayo Clinic, Northwestern University, St. Mary's Medical Center, San Diego Veterans Healthcare System, University of Pennsylvania, Washington University School of Medicine
- Study start
- 13 Nov 2012 (actual)
- Primary completion
- 24 Jun 2015 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Posted 18 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspiration Therapy | Experimental | Device: Aspiration Therapy (AspireAssist), Behavioral: Lifestyle TherapyAspiration Therapy and Lifestyle Therapy |
| Lifestyle Therapy | Active comparator | Behavioral: Lifestyle TherapyLifestyle Therapy only |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Measured BMI of 35.0-55.0 kg/m2 at time of screening.
- 21- 65 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.
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspiration Therapy (AspireAssist)Also: AspireAssist Aspiration Therapy SystemUse of the AspireAssist device in aspiration therapy | Device | Aspiration Therapy |
| Lifestyle TherapyAlso: Lifestyle Behavioral TherapyLifestyle therapy is a behavioral, diet and physical activity education program | Behavioural | Aspiration Therapy, Lifestyle Therapy |
Primary outcome
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.
13 secondary outcomes
Mean Percent Total Body Weight Loss
Time frame: 52 weeks
Percent of Subjects With ≥10% Total Body Weight Loss
Time frame: 52 weeks
Mean Percent Change in Serum Lipids
Time frame: 52 weeks
Mean Percent Change in Blood Pressure
Time frame: 52 weeks
Mean Change in Score for IWQOL Questionnaire
Time frame: 52 weeks
Mean Change in Hemoglobin A1C
Time frame: 52 weeks
Procedural Success
Time frame: 52 weeks
Change in Medication for Hypertension
Time frame: 52 weeks
Change in Medications for Dyslipidemia
Time frame: 52 weeks
Change in Medications for Type 2 Diabetes
Time frame: 52 weeks
Change in Number of Subjects on Hypertension Medication
Time frame: 52 weeks
Change in Number of Subjects on Dyslipidemia Medications
Time frame: 52 weeks
Change in Number of Subjects on Diabetes Medication
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Aspire Bariatrics, Inc. Study Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Thompson, MS, MD principal investigator
Brigham and Women's Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspiration Therapy (AspireAssist) and Lifestyle Therapy in people with Obesity, run by Aspire Bariatrics, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Excess Weight Loss (%EWL) (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.