NCT01766037: PATHWAY

Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study

Completed NA Results posted Last updated 27 January 2020

What this trial tests

NA trial testing Aspiration Therapy (AspireAssist) in Obesity in 171 participants. Completed in 30 March 2019.

Timeline

13 November 2012

Primary endpoint
24 June 2015

30 March 2019

Quick facts

Lead sponsor	Aspire Bariatrics, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	171
Start date	13 November 2012
Primary completion	24 June 2015
Estimated completion	30 March 2019
Sites	10 locations across United States

Drugs / interventions tested

• Aspiration Therapy (AspireAssist)
• Lifestyle Therapy

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Aspire Bariatrics, Inc.

Who can join

Adults 21 to 65, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Percent Excess Weight Loss (%EWL) Primary · 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.

Group	Value	95% CI
Aspiration Therapy	31.5	± 26.7
Lifestyle Therapy	9.8	± 15.5

% of Subjects Who Achieve >25% EWL Primary · 52 weeks

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

Group	Value	95% CI
Aspiration Therapy	56.8	49.0 – 64.5
Lifestyle Therapy	22.0	15.3 – 28.1

Mean Percent Total Body Weight Loss Secondary · 52 weeks

i) Mean percent absolute weight loss in AT compared to Control group

Group	Value	95% CI
Aspiration Therapy	12.1	± 9.6
Lifestyle Therapy	3.6	± 6.0

Percent of Subjects With ≥10% Total Body Weight Loss Secondary · 52 weeks

ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group

Group	Value	95% CI
Aspiration Therapy	58.6	50.3 – 66.6
Lifestyle Therapy	11.9	5.7 – 21.1

Mean Percent Change in Serum Lipids Secondary · 52 weeks

iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group

High Density Lipoprotein

Group	Value	95% CI
Aspiration Therapy	8.1	4.2 – 12.0
Lifestyle Therapy	1.7	-3.8 – 7.2

Low Density Lipoprotein

Group	Value	95% CI
Aspiration Therapy	-4.2	-8.5 – 0.1
Lifestyle Therapy	-1.8	-8.8 – 5.2

Triglycerides

Group	Value	95% CI
Aspiration Therapy	-9.9	-17.7 – -2.0
Lifestyle Therapy	0.1	-15.9 – 16.1

Mean Percent Change in Blood Pressure Secondary · 52 weeks

iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group

Systolic Pressure

Group	Value	95% CI
Aspiration Therapy	-1.2	-4.0 – 1.5
Lifestyle Therapy	-2.5	-5.9 – 0.9

Diastolic Pressure

Group	Value	95% CI
Aspiration Therapy	-2.6	-5.2 – 0.1
Lifestyle Therapy	0.5	-4.1 – 5.2

Mean Change in Score for IWQOL Questionnaire Secondary · 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'

Group	Value	95% CI
Aspiration Therapy	16.3	12.5 – 20.1
Lifestyle Therapy	11.7	5.5 – 17.9

Mean Change in Hemoglobin A1C Secondary · 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.

Group	Value	95% CI
Aspiration Therapy	-2.3	-3.7 – -0.9
Lifestyle Therapy	-0.37	-0.77 – -0.03

Procedural Success Secondary · 52 weeks

vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy

Group	Value	95% CI
Aspiration Therapy	99

Change in Medication for Hypertension Secondary · 52 weeks

Percent change in the number of medications taken by subjects for hypertension

Group	Value	95% CI
Aspiration Therapy	-53.5
Lifestyle Therapy	-9.4

Change in Medications for Dyslipidemia Secondary · 52 weeks

Percent change in the number of medications taken by subjects for dyslipidemia

Group	Value	95% CI
Aspiration Therapy	-23.1
Lifestyle Therapy	-7.7

Change in Medications for Type 2 Diabetes Secondary · 52 weeks

Percent change in the number of medications taken by subjects for Type 2 Diabetes

Group	Value	95% CI
Aspiration Therapy	-33.0
Lifestyle Therapy	-14.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 52 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Aspiration Therapy

Serious: 4/111 (4%)

Deaths: —

Lifestyle Therapy

Serious: 0/60 (0%)

Deaths: —

Serious adverse events (4 terms)

Reaction	System	Aspiration Therapy	Lifestyle Therapy
Peritonitis	Surgical and medical procedures	—	—
Abdominal Pain	Gastrointestinal disorders	—	—
Prepyloric Ulceration	Gastrointestinal disorders	—	—
A-Tube Replacement	Surgical and medical procedures	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Aspiration Therapy	Lifestyle Therapy
Granulation Tissue	Skin and subcutaneous tissue disorders	—	—
Abdominal Pain (post procedure)	Gastrointestinal disorders	—	—
Peristomal Discharge	Skin and subcutaneous tissue disorders	—	—
Nausea / Vomiting	Gastrointestinal disorders	—	—
Abdominal Discomfort	Gastrointestinal disorders	—	—
Peristomal Infection	Infections and infestations	—	—
Abdominal Pain (after 4 weeks)	Gastrointestinal disorders	—	—
Change in Bowel Habits	Gastrointestinal disorders	—	—

Most-reported serious reactions: Peritonitis, Abdominal Pain, Prepyloric Ulceration, A-Tube Replacement.

Data from ClinicalTrials.gov NCT01766037 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial.
   Thompson CC, Abu Dayyeh BK, Kushner R, Sullivan S, et al · · 2017 · cited 103× · PMID 27922026 · DOI 10.1038/ajg.2016.500