Trial Outcomes & Findings for Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma (NCT NCT01025076)

Results Overview

Body weight changes at 6 months after StomaphyX procedure comparing to baseline weight.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

At 6 months comparing to baseline weight

Results posted on

2017-03-10

Withdrawal data not reported

Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma

Baseline characteristics by cohort
Measure	StomaphX n=14 Participants Patients with weight gain following VBG had endoluminal pouch reduction performed using the StomaphyXTM device in revisional bariatric surgery clinic
Age, Continuous	46.4 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Pre-operative weight	119.5 Kg STANDARD_DEVIATION 25.9 • n=5 Participants

Timeframe: At 6 months comparing to baseline weight

Body weight changes at 6 months after StomaphyX procedure comparing to baseline weight.

Outcome measures
Measure	StomaphX n=14 Participants
Primary Outcome: Change in Body Weight	9.6 kg Standard Deviation 7.9

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	StomaphX n=14 participants at risk
Surgical and medical procedures headache	14.3% 2/14 • Number of events 2
Surgical and medical procedures low back pain	7.1% 1/14 • Number of events 1

Royal Alexandra Hospital/CAMIS

Phone: 7807356735