Trial Outcomes & Findings for Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial (NCT NCT05559866)
NCT ID: NCT05559866
Last Updated: 2025-10-23
Results Overview
The primary outcomes are durability of plications and endoscopic sutures on repeat endoscopy at 6 months, in the two randomized arms. Endoscopic scale runs from 0 to 3. A lower score indicates less durability and a higher score indicates greater durability.
COMPLETED
NA
45 participants
6 months
2025-10-23
Participant Flow
Recruitment occurred at a single center, Mayo Clinic Rochester. Recruitment was primarily achieved through direct advertising leading subjects to self-refer, as well as physician referrals. 45 patients were enrolled, 24 were randomized and underwent study treatment either in the ESG arm or the ESG-HAPC arm. The last patient was enrolled in November of 2023 and the last treatment procedure was completed in January of 2024.
Of the 45 enrolled participants only 24 moved forward to randomization and treatment. Reasons for exclusion included non-qualifying BMI, disqualifying psychological intake findings, findings on laboratory testing or MRI, and patient refusal to complete screening activities.
Participant milestones
| Measure |
Control Group: ESG
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
6 Month Post-procedure Visit
|
12
|
12
|
|
Overall Study
12 Month Post-procedure Visit
|
11
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Control Group: ESG
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial
Baseline characteristics by cohort
| Measure |
Control Group: ESG
n=12 Participants
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
n=12 Participants
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 6.2 • n=39 Participants
|
47.8 years
STANDARD_DEVIATION 9.2 • n=41 Participants
|
45.5 years
STANDARD_DEVIATION 11.27 • n=35 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
BMI
|
36.6 kg/m²
STANDARD_DEVIATION 2.4 • n=39 Participants
|
36.6 kg/m²
STANDARD_DEVIATION 2.1 • n=41 Participants
|
36.6 kg/m²
STANDARD_DEVIATION 2.22 • n=35 Participants
|
|
Hypertension
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Hyperlipidemia
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Sleep Apnea
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Mood Disorder
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Current smoker
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Current alcohol use
|
10 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Type 2 diabetes mellitus
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: One participant in the ESG arm elected not to undergo the endoscopy at which the durability assessment is performed.
The primary outcomes are durability of plications and endoscopic sutures on repeat endoscopy at 6 months, in the two randomized arms. Endoscopic scale runs from 0 to 3. A lower score indicates less durability and a higher score indicates greater durability.
Outcome measures
| Measure |
Control Group: ESG
n=11 Participants
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
n=12 Participants
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Durability
Mid Stomach - bridging fibrosis
|
2.8 Score on a scale
Standard Deviation 0.4
|
1.9 Score on a scale
Standard Deviation 0.7
|
|
Durability
Proximal Stomach - Tubular form
|
1.2 Score on a scale
Standard Deviation 0.1
|
3.0 Score on a scale
Standard Deviation 0.12
|
|
Durability
Proximal stomach - Bridging fibrosis
|
1.4 Score on a scale
Standard Deviation 0.7
|
3.0 Score on a scale
Standard Deviation 0.0
|
|
Durability
Proximal stomach - accommodation to insufflation
|
1.4 Score on a scale
Standard Deviation 0.7
|
3.0 Score on a scale
Standard Deviation 0
|
|
Durability
Mid-stomach - tubular form
|
2.8 Score on a scale
Standard Deviation 0.4
|
1.8 Score on a scale
Standard Deviation 0.7
|
|
Durability
Mid Stomach - accommodation to insufflation
|
2.8 Score on a scale
Standard Deviation 0.4
|
1.8 Score on a scale
Standard Deviation 0.6
|
|
Durability
Distal Stomach - tubular form
|
1.3 Score on a scale
Standard Deviation 0.6
|
2.2 Score on a scale
Standard Deviation 0.6
|
|
Durability
Distal stomach - bridging fibrosis
|
1.5 Score on a scale
Standard Deviation 0.7
|
2.0 Score on a scale
Standard Deviation 0.7
|
|
Durability
Distal stomach - accommodation to insufflation
|
1.2 Score on a scale
Standard Deviation 0.4
|
1.9 Score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 6 monthCompared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Percent total body weight loss was analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). Total body weight loss is calculated as follows: Total Body Weight Loss (%) = \[ (Starting Weight - Current Weight) / Starting Weight \] × 100
Outcome measures
| Measure |
Control Group: ESG
n=12 Participants
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
n=12 Participants
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Percent Total Body Weight Loss (%TBWL)
|
19.5 Percentage
Standard Deviation 6.2
|
18.8 Percentage
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 6 and 12 monthPopulation: All 24 patients completed their weigh in at 6 months, 2 patients in the ESG arm did not weigh in at 12 months (one due to patient withdrawal, one due to patient noncompliance).
Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Percent excess weight loss was analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). % EWL = (actual weight lost / excess body weight) x 100 Where excess body weight represents the difference in starting weight and ideal weight (weight corresponding to a body mass index of 25 kg/m\^2)
Outcome measures
| Measure |
Control Group: ESG
n=12 Participants
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
n=12 Participants
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Percent Excess Weight Loss (%EWL)
6 Months
|
101.5 Percentage
Standard Deviation 73.68
|
88.69 Percentage
Standard Deviation 70.92
|
|
Percent Excess Weight Loss (%EWL)
12 Months
|
125.49 Percentage
Standard Deviation 87.96
|
187.15 Percentage
Standard Deviation 200.95
|
SECONDARY outcome
Timeframe: 6 monthCompared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Blood pressure scores analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index).
Outcome measures
| Measure |
Control Group: ESG
n=12 Participants
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
n=12 Participants
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Blood Pressure
Systolic
|
113.8 mm HG
Interval 101.0 to 125.0
|
119.8 mm HG
Interval 99.0 to 150.0
|
|
Blood Pressure
Diastolic
|
73.9 mm HG
Interval 57.0 to 85.0
|
76.3 mm HG
Interval 63.0 to 99.0
|
SECONDARY outcome
Timeframe: 6 monthCompared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis
Outcome measures
| Measure |
Control Group: ESG
n=12 Participants
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
n=12 Participants
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Percentage of Glycated Hemoglobin (% HbA1c)
|
4.9 Percentage
Standard Deviation 0.28
|
5.1 Percentage
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: 6 monthCompared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. 8 quality of life domains assessed, domains scores range 0-100 with a lower score indicating a worse outcome, and a higher score indicating a better outcome.
Outcome measures
| Measure |
Control Group: ESG
n=12 Participants
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
n=12 Participants
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Questionnaire: Short Form (36) Health Survey [SF-36]
Physical Functioning
|
98.3 Score on a scale
Standard Deviation 3.3
|
89.6 Score on a scale
Standard Deviation 14.5
|
|
Questionnaire: Short Form (36) Health Survey [SF-36]
Role Limitations Due to Physical Health
|
97.9 Score on a scale
Standard Deviation 7.2
|
93.8 Score on a scale
Standard Deviation 21.7
|
|
Questionnaire: Short Form (36) Health Survey [SF-36]
Emotional well-being
|
81.7 Score on a scale
Standard Deviation 15.8
|
86.7 Score on a scale
Standard Deviation 13.2
|
|
Questionnaire: Short Form (36) Health Survey [SF-36]
Bodily Pain
|
87.7 Score on a scale
Standard Deviation 16.6
|
80.6 Score on a scale
Standard Deviation 22.7
|
|
Questionnaire: Short Form (36) Health Survey [SF-36]
General Health Perceptions
|
77.5 Score on a scale
Standard Deviation 13.1
|
79.2 Score on a scale
Standard Deviation 7.9
|
|
Questionnaire: Short Form (36) Health Survey [SF-36]
Vitality (Energy and Fatigue)
|
60.4 Score on a scale
Standard Deviation 19.1
|
75.4 Score on a scale
Standard Deviation 13.2
|
|
Questionnaire: Short Form (36) Health Survey [SF-36]
Social Functioning
|
89.6 Score on a scale
Standard Deviation 19.1
|
89.6 Score on a scale
Standard Deviation 17.5
|
|
Questionnaire: Short Form (36) Health Survey [SF-36]
Role Limitations Due to Emotional Problems
|
88.88 Score on a scale
Standard Deviation 29.6
|
100 Score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 6 monthCompared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. 5 quality of life domains are scored, a higher score indicates higher quality of life relative to that domain and lower score indicates worse quality of life relative to that domain. Physical function domain (11 items scored 1-5) total scores ranging 11-55 Self-esteem domain (seven items scored 1-5) total scores ranging 7-35 Sexual life domain (four items each scored 1-5) total scores ranging 4-20 Public distress domain (five items each scored 1-5) total scores ranging 5-25 Work-related domain (four items each scored 1-5) total scores ranging 4-20
Outcome measures
| Measure |
Control Group: ESG
n=12 Participants
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
n=12 Participants
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Questionnaire: Impact of Weight on Quality of Life (IWQOL)
Self-esteem score
|
14 Score on a scale
Standard Deviation 4.8
|
12 Score on a scale
Standard Deviation 6.3
|
|
Questionnaire: Impact of Weight on Quality of Life (IWQOL)
Public distress score
|
5.4 Score on a scale
Standard Deviation 1.5
|
5.25 Score on a scale
Standard Deviation 0.6
|
|
Questionnaire: Impact of Weight on Quality of Life (IWQOL)
Physical function score
|
13.08 Score on a scale
Standard Deviation 3.6
|
12.91 Score on a scale
Standard Deviation 2.5
|
|
Questionnaire: Impact of Weight on Quality of Life (IWQOL)
Sexual life score
|
7.3 Score on a scale
Standard Deviation 3.0
|
6.6 Score on a scale
Standard Deviation 3.1
|
|
Questionnaire: Impact of Weight on Quality of Life (IWQOL)
Work-related score
|
4 Score on a scale
Standard Deviation 0.7
|
4.08 Score on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 6 monthCompared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Score range 0-27, with a higher score indicating more severe symptoms and a lower score indicating less severe or no symptoms.
Outcome measures
| Measure |
Control Group: ESG
n=12 Participants
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
n=12 Participants
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Questionnaire: Patient Health Questionnaire-9 (PHQ-9)
|
1.8 Score on a scale
Interval 0.0 to 5.0
|
1.1 Score on a scale
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: 6 monthCompared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Scored across three behavioral domains, higher scores in each subscale indicate a greater tendency towards that particular eating behavior. Cognitive Restraint Score range 6-28 Uncontrolled Eating Score range 9-36 Emotional Eating Score range 3-12
Outcome measures
| Measure |
Control Group: ESG
n=12 Participants
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
n=12 Participants
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Questionnaire: Eating Behavior
Cognitive restraint score
|
18.4 Score on a scale
Standard Deviation 2.4
|
18.8 Score on a scale
Standard Deviation 3.0
|
|
Questionnaire: Eating Behavior
Uncontrolled eating score
|
14.1 Score on a scale
Standard Deviation 4.1
|
11.6 Score on a scale
Standard Deviation 3.1
|
|
Questionnaire: Eating Behavior
Emotional eating score
|
5.3 Score on a scale
Standard Deviation 2.3
|
4.2 Score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 6 monthCompared between treatment arms by Pearson Chi-square test. % EWL = (actual weight lost / excess body weight) x 100 Where excess body weight represents the difference in starting weight and ideal weight (weight corresponding to a body mass index of 25 kg/m\^2)
Outcome measures
| Measure |
Control Group: ESG
n=12 Participants
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
n=12 Participants
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Binary Outcome: ≥25% Reduction in Percent Excess Weight Loss (%EWL)
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 6 monthCompared between treatment arms by Pearson Chi-square test.
Outcome measures
| Measure |
Control Group: ESG
n=11 Participants
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
n=12 Participants
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Binary Outcome: Incidence of Esophagitis
|
0 Participants
|
0 Participants
|
Adverse Events
Control Group: ESG
Treatment Group: ESG + HAPC
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Group: ESG
n=12 participants at risk
Subjects will undergo ESG utilizing approved device alone
|
Treatment Group: ESG + HAPC
n=12 participants at risk
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
2/12 • Number of events 2 • From enrollment until end of follow up, up to 52 weeks post-treatment
|
25.0%
3/12 • Number of events 3 • From enrollment until end of follow up, up to 52 weeks post-treatment
|
|
Gastrointestinal disorders
Constipation
|
33.3%
4/12 • Number of events 4 • From enrollment until end of follow up, up to 52 weeks post-treatment
|
33.3%
4/12 • Number of events 4 • From enrollment until end of follow up, up to 52 weeks post-treatment
|
|
Gastrointestinal disorders
GERD
|
16.7%
2/12 • Number of events 2 • From enrollment until end of follow up, up to 52 weeks post-treatment
|
16.7%
2/12 • Number of events 2 • From enrollment until end of follow up, up to 52 weeks post-treatment
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • From enrollment until end of follow up, up to 52 weeks post-treatment
|
0.00%
0/12 • From enrollment until end of follow up, up to 52 weeks post-treatment
|
|
General disorders
Fatigue
|
0.00%
0/12 • From enrollment until end of follow up, up to 52 weeks post-treatment
|
8.3%
1/12 • Number of events 1 • From enrollment until end of follow up, up to 52 weeks post-treatment
|
|
General disorders
Patchy tongue lesions
|
0.00%
0/12 • From enrollment until end of follow up, up to 52 weeks post-treatment
|
8.3%
1/12 • Number of events 1 • From enrollment until end of follow up, up to 52 weeks post-treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place