ObesityHAPCETNCT05559866
Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial
A study testing Apollo ESG with ERBE HAPC and Apollo ESG in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to evaluate the safety and effectiveness of combined Hybrid Argon Plasma Coagulation (HAPC) and Endoscopic Sleeve Gastroplasty (ESG) for weight loss and improvement in obesity-related co-morbidities compared to ESG alone in participants with a BMI ≥ 30 and ≤40 kg/m² who have failed to achieve… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Apollo ESG with ERBE HAPC and Apollo ESG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2022to 17 Jan 2025
- 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
- BMI ≥ 30 and ≤40 kg/m²
- Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
- History of failure with non-surgical weight-loss methods.
- Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling.
- Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow-up visits.
- Ability to give informed consent.
- Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
Who cannot join
- History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy).
- Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
- Prior open or laparoscopic bariatric surgery.
- Prior surgery of any kind on the esophagus, stomach, or any type of hiatal hernia surgery.
- Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer, or specific inflammatory disease such as Crohn's disease or celiac disease.
- Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
Show all 35Show fewer
- Gastrointestinal stromal tumors, history of premalignant gastric lesions (intestinal metaplasia), history of familial and nan-familial adenomatous syndromes.
- A gastric mass or gastric polyps > 1 cm in size.
- A hiatal hernia > 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
- A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
- Achalasia or any other severe esophageal motility disorder
- Severe coagulopathy.
- Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C≥9.
- Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy.
- Chronic abdominal pain.
- Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation.
- Hepatic insufficiency or cirrhosis.
- Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.
- Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
- Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up.
- Patients receiving daily prescribed treatment with high dose aspirin (> 81mg daily), anti-inflammatory agents, anticoagulants, or other gastric irritants.
- Patients who are unable or unwilling to take prescribed proton pump inhibitor medication.
- Patients who are pregnant or breast-feeding.
- Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months.
- Subjects with severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs.
- Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications.
- Subjects who are taking corticosteroids, immunosuppressants, and narcotics.
- Symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary artery disease.
- Pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer.
- Diagnosis of autoimmune connective tissue disorder (e.g. Systemic lupus erythematosus, scleroderma) or immunocompromised.
- Specific diagnosed genetic disorder such as Prader Willi syndrome.
- Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
- Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.
- At the discretion of the PI for subject safety
- If minority inclusion population target of 10% has not been reached by the 90% enrollment mark (example 21 of 24 subjects), the remaining enrollments will be reserved for minority subjects (example 3 of 24 subjects).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial (HAPCET): A Single-center Randomized Controlled Trial
This study is being done to evaluate the safety and effectiveness of combined Hybrid Argon Plasma Coagulation (HAPC) and Endoscopic Sleeve Gastroplasty (ESG) for weight loss and improvement in obesity-related co-morbidities compared to ESG alone in participants with a BMI ≥ 30 and ≤40 kg/m² who have failed to achieve and maintain weight loss with a non-surgical program.
- Conditions
- Obesity
- Being tested
- Apollo ESG with ERBE HAPC, Apollo ESG
- Keywords
- ESG, Hybrid APC
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo ESG with ERBE HAPCDevice
Utilizing two approved devices in combination to assess durability of suturing.
Apollo ESGDevice
Using only Apollo ESG as approved per label.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: ESG | Active comparator | Subjects will undergo ESG utilizing approved device alone Receives: Device: Apollo ESG |
| Treatment Group: ESG + HAPC | Experimental | Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label. Receives: Device: Apollo ESG with ERBE HAPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durability
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.
Measured: 6 months
Secondary outcomes (10)
Percent Total Body Weight Loss (%TBWL)
Compared 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
Measured: 6 month
Percent Excess Weight Loss (%EWL)
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)
Measured: 6 and 12 month
Blood Pressure
Compared 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).
Measured: 6 month
Percentage of Glycated Hemoglobin (% HbA1c)
Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis
Measured: 6 month
Questionnaire: Short Form (36) Health Survey [SF-36]
Compared 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.
Measured: 6 month
Questionnaire: Impact of Weight on Quality of Life (IWQOL)
Compared 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
Measured: 6 month
Questionnaire: Patient Health Questionnaire-9 (PHQ-9)
Compared 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.
Measured: 6 month
Questionnaire: Eating Behavior
Compared 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
Measured: 6 month
Binary Outcome: ≥25% Reduction in Percent Excess Weight Loss (%EWL)
Compared 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)
Measured: 6 month
Binary Outcome: Incidence of Esophagitis
Compared between treatment arms by Pearson Chi-square test.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start18 Nov 2022
- Primary completion2 Aug 2024
- Study completion17 Jan 2025
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe Elektromedizin GmbH
- Responsible party
- Principal investigator, Omar Ghanem, Mayo Clinic
- Investigators
- Omar Ghanem, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559866
- Sponsor's protocol ID
- 22-001202
- Acronym
- HAPCET
- Status last verified
- Oct 2025
- First submitted
- 26 Sep 2022
- Last updated
- 23 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial (HAPCET): A Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05559866
- Acronym / sponsor ID
- HAPCET / 22-001202
- Conditions
- Obesity
- Keywords
- ESG, Hybrid APC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Erbe Elektromedizin GmbH
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Posted 23 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to evaluate the safety and effectiveness of combined Hybrid Argon Plasma Coagulation (HAPC) and Endoscopic Sleeve Gastroplasty (ESG) for weight loss and improvement in obesity-related co-morbidities compared to ESG alone in participants with a BMI ≥ 30 and ≤40 kg/m² who have failed to achieve and maintain weight loss with a non-surgical program.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Control Group: ESG | Active comparator | Device: Apollo ESGSubjects will undergo ESG utilizing approved device alone |
| Treatment Group: ESG + HAPC | Experimental | Device: Apollo ESG with ERBE HAPCSubjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI ≥ 30 and ≤40 kg/m²
- Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
- History of failure with non-surgical weight-loss methods.
- Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling.
- Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow-up visits.
Key exclusion criteria (35 listed)
- History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy).
- Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
- Prior open or laparoscopic bariatric surgery.
- Prior surgery of any kind on the esophagus, stomach, or any type of hiatal hernia surgery.
- Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer, or specific inflammatory disease such as Crohn's disease or celiac disease.
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 |
|---|---|---|
| Apollo ESG with ERBE HAPCUtilizing two approved devices in combination to assess durability of suturing. | Device | Treatment Group: ESG + HAPC |
| Apollo ESGUsing only Apollo ESG as approved per label. | Device | Control Group: ESG |
Primary outcome
Durability
Time frame: 6 months
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.
10 secondary outcomes
Percent Total Body Weight Loss (%TBWL)
Time frame: 6 month
Percent Excess Weight Loss (%EWL)
Time frame: 6 and 12 month
Blood Pressure
Time frame: 6 month
Percentage of Glycated Hemoglobin (% HbA1c)
Time frame: 6 month
Questionnaire: Short Form (36) Health Survey [SF-36]
Time frame: 6 month
Questionnaire: Impact of Weight on Quality of Life (IWQOL)
Time frame: 6 month
Questionnaire: Patient Health Questionnaire-9 (PHQ-9)
Time frame: 6 month
Questionnaire: Eating Behavior
Time frame: 6 month
Binary Outcome: ≥25% Reduction in Percent Excess Weight Loss (%EWL)
Time frame: 6 month
Binary Outcome: Incidence of Esophagitis
Time frame: 6 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Omar Ghanem, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apollo ESG with ERBE HAPC and Apollo ESG in people with Obesity, run by Mayo Clinic at 1 site 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 7 inclusion and 35 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 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 23 Oct 2025). 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?
Durability (time frame: 6 months). 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 23 Oct 2025.