|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P150024 / PAS001 |
| Study Name |
PATHWAY Clinical Trial PAS
|
| Device Name |
AspireAssist
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of premarket cohorts
|
| Study Population |
Subjects who are active participants in the PATHWAY pivotal trial under G120045
|
| Sample Size |
46 subjects are currently enrolled in the study
|
| Key Study Endpoints |
n/a
|
| Follow-up Visits and Length of Follow-up |
2 years post device explant
Bi-monthly for six months and at one and two years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
31 patients
|
| Actual Number of Sites Enrolled |
7 sites
|
| Patient Follow-up Rate |
Year 3 - 73%, year 4 - 50%, year 5 - 33%
|
| Final Safety Findings |
11 adverse events in 11 patients were reported during the postapproval study (10 device related, and 1 procedure related. Four of these 11 adverse events were “Persistent fistula.” Only one serious adverse event classified as “A-Tube dislodgement” was reported.
There were not eating disorders reported during the post approval study.
|
| Final Effect Findings |
The efficacy of the device while implanted was assessed by percent excess weight loss (%EWL) and total body loss (%TBL). Other efficacy study endpoints while the device was implanted included the change in obesity-related comorbidities (blood pressure, lipid levels,
triglycerides, Hemoglobin A1c or HbA1c) and change in medications.
%EWL: The results ranged from 44.7% on the third year of follow-up, 50.8% in the fourth year and 64.8%
in the fifth or last year.
%EWL Post-Explant: The results ranged from 24.0% at 2-months of follow-up, 27.1% at 4-months, 20.0%
at 6-months, 9.8% at 1-year and 4.5% at 2 years post-explant.
%TBL: The results ranged from 16.6% on the third year of follow-up, 18.7% in the fourth year and 24.3%
in the fifth or last year.
%TBL Post-explant: The results ranged from 8.9% at 2-months of follow-up, 9.8% at 4-months, 7.2% at 6-
months, 3.5% at 1-year and 1.3% at 2 years post-explant.
Co-morbidities:
SBP: The average systolic blood pressure decreased from 124.4 (mmHg) on the third year of follow-up,
116.3 in the fourth year and 117.8 in the fifth or last year.
DBP: The average diastolic blood pressure slightly decreased from 77.6 (mmHg) on the third year of
follow-up, 77.0 in the fourth year and 73.7 in the fifth or last year.
HbA1c: This laboratory measurement was only reported from one patient for years 3 and 4 of the
follow-up, being 5.6 for the third year and 5.4 for the fourth year.
Quality of Life (IWQOL):
Seven patients completed the first-year and three completed the second-year post-explant follow-up
milestones. When compiled, the standardized average quality of life scores at year 1 and 2 post-explant improved from baseline by about 19%.
Eating Disorders (EDE):
Seven patients completed the 1-year post-explant follow-up milestone to date, and three completed the 2-year post explant follow-up. Testing showed no signs of eating disorders.
|
| Study Strengths & Weaknesses |
Strength: long follow-up. Weaknesses: small sample size, low follow-up rate, and there is no comparator group.
|
| Recommendations for Labeling Changes |
Yes, the results of the post-approval study should be included.
|
