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Procedure
HAPC-ESG for Obesity (HAPCET2 Trial)
N/A
Waitlist Available
Led By Christopher E McGowan, MD, MSCR
Research Sponsored by True You Weight Loss
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 month
Awards & highlights
HAPCET2 Trial Summary
This trial will compare a new bariatric procedure (HAPC-ESG) to traditional ESG to evaluate safety, weight loss and durability.
Who is the study for?
Adults aged 21-65 with a BMI between 30 and ≤40 kg/m², who have unsuccessfully tried non-surgical weight-loss methods. Participants must be willing to follow the study's diet restrictions, live near Cary, NC for follow-ups, use birth control if applicable, and have internet access. Excluded are those with certain past surgeries or conditions like severe coagulopathy, insulin-dependent diabetes (HgbA1C≥9), gastrointestinal issues including large hiatal hernias (>4cm), or on specific medications that affect gastric emptying.Check my eligibility
What is being tested?
The trial is testing a new procedure combining Hybrid Argon Plasma Coagulation (HAPC) with Endoscopic Sleeve Gastroplasty (ESG) against the standard ESG alone. The goal is to see if adding HAPC improves weight loss outcomes and durability of the treatment compared to just using ESG.See study design
What are the potential side effects?
Potential side effects may include discomfort at the procedure site, bleeding due to thermal hemostasis from APC application, infection risks from endoscopy procedures, as well as possible nutritional deficiencies or changes in digestion due to altered stomach structure post-procedure.
HAPCET2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Durability assessed by blinded physician(s) with expertise in endoscopic sleeve gastroplasty (ESG) procedures graded according to a priori standardized criteria.
Secondary outcome measures
%EWL
%TBWL
Binary Outcomes: ≥25% change in %EWL
+7 moreHAPCET2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hybrid Argon Plasma Coagulation and Endoscopic Sleeve GastroplastyExperimental Treatment2 Interventions
Hybrid APC will be utilized to first ablate the gastric mucosa along the greater curve of the stomach, followed immediately by endoscopic full-thickness tissue acquisition and plication using 2-0 Prolene synthetic sutures via the Apollo ESG platform.
Group II: Endoscopic Sleeve GastroplastyActive Control1 Intervention
Endoscopic full-thickness tissue acquisition and plication using 2-0 Prolene synthetic sutures via the Apollo ESG platform.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endoscopic Sleeve Gastroplasty
2017
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
Apollo Endosurgery, Inc.Industry Sponsor
12 Previous Clinical Trials
2,890 Total Patients Enrolled
7 Trials studying Obesity
1,999 Patients Enrolled for Obesity
Erbe USA IncorporatedOTHER
10 Previous Clinical Trials
1,103 Total Patients Enrolled
4 Trials studying Obesity
47 Patients Enrolled for Obesity
True You Weight LossLead Sponsor
2 Previous Clinical Trials
20 Total Patients Enrolled
2 Trials studying Obesity
20 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe digestive system conditions like Crohn's or celiac disease.I have conditions that could cause bleeding in my upper digestive tract.I have a large hiatal hernia or severe acid reflux that's hard to control.I have had surgery on my esophagus, stomach, or for a hiatal hernia.I have had stomach or gut surgery, but not just for gallbladder or appendix.I have had stomach surgery that caused complications like blockage or sticky tissues.I have a stomach mass or polyps larger than 1 cm.I have had weight loss surgery before.I have a severe blood clotting disorder.I have liver problems or cirrhosis.I have a gastrointestinal stromal tumor or a related condition.I have a severe disorder affecting my esophagus movement.I have not taken weight-loss medications or therapies in the last 6 months.I am currently taking corticosteroids, immunosuppressants, or narcotics.I have diabetes that requires insulin or my HgbA1C is 9 or higher.I cannot or will not take proton pump inhibitor medication.I am willing to follow a medically supervised diet and behavior program.I am on daily medication like high dose aspirin or blood thinners.I do not have severe heart, lung, or serious diseases.I have been diagnosed with a specific genetic disorder like Prader Willi syndrome.I have a structural issue in my throat or esophagus, like a narrowing or pouch.I have a hormone-related condition that affects my weight.I take medications that are affected by how quickly my stomach empties.I am between 21 and 65 years old.I have an autoimmune disorder or a weakened immune system.I have a lung condition like COPD, pneumonia, or lung cancer.I have ongoing stomach pain.I have severe movement problems in my digestive system.I have heart problems like heart failure, irregular heartbeat, or unstable heart disease.I have tried losing weight without surgery but it didn't work.I have a serious health issue that makes endoscopy risky for me.I live close enough to Cary, NC to travel for all my appointments.I have an eating disorder such as bulimia or binge eating.I agree to use effective birth control if I can have children.
Research Study Groups:
This trial has the following groups:- Group 1: Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty
- Group 2: Endoscopic Sleeve Gastroplasty
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the participant cohort for this clinical trial restricted to seniors in any way?
"As indicated by the eligibility criteria, applicants of this clinical trial must be between 21 and 65 years old."
Answered by AI
How can I become a participant in this research study?
"Meeting the requisites for admission to this clinical trial, participants must suffer from obesity and be between 21 and 65 years old. The study is looking to recruit 48 patients in total."
Answered by AI
Is enrollment for this research trial still open?
"According to the records hosted on clinicaltrials.gov, this clinical trial is actively looking for participants. This study was first listed on May 1st of 2023 and its information has been recently updated as of May 12th of the same year."
Answered by AI
How many participants are being evaluated in this research project?
"Affirmative. According to clinicaltrials.gov, this medical trial is currently looking for participants and was initially posted on the 1st of May 2023 with its last update occurring on 12th of May 23rd. The research requires 48 individuals from a single site"
Answered by AI
Who else is applying?
What site did they apply to?
True You Weight Loss
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I have tried for years to lose and maintain weight loss. I can lose, but I can never maintain.
PatientReceived 2+ prior treatments
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