ObesityINSPIRONCT06272201
Incisionless Suture Plications in a POSE2.0 Obesity Study
A study testing POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors in people with Obesity, run by USGI Medical.
Trial summary
This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (sutures placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program… Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Subject agrees to be compliant with study requirements and adhere to post-operative dietary \& exercise recommendations for the duration of the study.
- Subjects between the ages of 22-65 years.
- History or failure with non-surgical weight-loss methods.
- If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
- Have a Body Mass Index (BMI) of ≥ 30 and ≤ 50 kg/m².
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- Absence of current severe systemic disease (including, but not limited to: coronary artery disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, and chronic renal disease).
- Agrees to forego any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
- Have not taken any prescription or over-the-counter weight loss medications in the last 6 months, with exception of medications used to manage T2D so long as the subject has been on a stable dose and weight has persisted.
- Residing within a reasonable distance from the Investigator's treating office (~50 miles) and willing and able to travel to the Investigator's office to complete all routine follow-up visits.
Who cannot join
- History of or intra-operative evidence of prior bariatric, gastric or esophageal surgery.
- Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.
- Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
- Large hiatal hernia (>3 cm) by history or as determined by pre-enrollment endoscopy.
- Pancreatic insufficiency/disease.
- History of gastroparesis or symptoms that would be suggestive of gastroparesis or generalized dysmotility (e.g., esophago-gastric motility issues and lower esophageal sphincter abnormalities).
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- Patients who are known to be pregnant or breast-feeding, or plan to become pregnant in the next 12 months.
- History of a known diagnosis or pre-existing symptom of rheumatoid arthritis, scleroderma, system lupus, or other autoimmune connective tissue disorder.
- Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6 months of Visit 1. Intranasal/inhaled steroids are acceptable.
- Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs), or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study.
- History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis.
- Active gastric erosion, lesion, or gastric/duodenal ulcer.
- History of or current platelet or coagulation dysfunction, such as hemophilia.
- History or present use of insulin or insulin derivatives for treatment of diabetes.
- Patients with type II diabetes mellitus on oral agents (not injectables) with HgA1c > 9 at the time of enrollment.
- Active smoker or someone who has been a smoker in the 6 months leading up to the study.
- Portal hypertension and/or varices.
- Patient has a history of drug or alcohol abuse or positive at screening for drug use.
- Patient is currently using marijuana/cannabis for either medicinal or recreational use, or has plans to start using over the next 12 months.
- Present or history of psychosis, bipolar disease, obsessive-compulsive disorder, binge eating, and/or other eating disorders after pre-enrollment history and medical /psychological assessment.
- Beck Depression Inventory (Short) Score ≥ 12, and/or uncontrolled depression after pre-enrollment psychological and medical assessment.
- Patient score >2 in any of the identified symptoms in the nausea/vomiting or bloating/distension domains on the Gastroparesis Cardinal Symptom Index (GCSI).
- Non-ambulatory or has significant impairment of mobility (i.e. cannot ambulate for 30 minutes).
- Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).
- Present or history of chronic abdominal pain.
- Participating in another clinical study that could compromise compliance with the POSE2.0 study (must be cleared with investigator and USGI Medical).
- Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
- Any other medical condition that would not permit elective endoscopy such as poor general health or history and/or symptoms of severe renal, hepatic, cardiac, and/or pulmonary disease, and/or physician's assessment that the subject is not an appropriate candidate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study (The INSPIRO Study)
This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (sutures placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP).
Read the detailed description
This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (g-Cath EZ Snowshoe Suture Anchors placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP).
- Conditions
- Obesity
- Being tested
- POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture AnchorsDevice
POSE2.0 (g-Cath EZ snowshoe suture anchors placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | POSE2.0 Treatment with Lifestyle Modification Receives: Device: POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors |
| Control | No intervention | Lifestyle Modification alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of total body weight loss (%TBWL) following randomization
To be deemed effective, the difference in %TBWL between the treatment group minus the control group must be significantly greater than 5%.
Measured: 12 months
Responder rate of at least 50% in the POSE2.0 treatment group
Responder defined as >5% TBWL
Measured: 12 months
Safety- Incidence of device and procedure related adverse events through 12 months
Incidence of device and procedure related adverse events through 12 months defined as Clavien-Dindo Class III or greater.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- USGI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barham Abu Dayyeh, MD, MPH, Principal investigator, Mayo ClinicErik Wilson, MD, Principal investigator, University of Texas Medical School at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272201
- Sponsor's protocol ID
- 50620 TPR
- Acronym
- INSPIRO
- Status last verified
- Apr 2026
- First submitted
- 14 Feb 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study (The INSPIRO Study)
- ClinicalTrials.gov ID
- NCT06272201
- Acronym / sponsor ID
- INSPIRO / 50620 TPR
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- USGI MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (sutures placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP).
Detailed description
This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (g-Cath EZ Snowshoe Suture Anchors placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture AnchorsPOSE2.0 Treatment with Lifestyle Modification |
| Control | No intervention | –Lifestyle Modification alone |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of signed and dated informed consent form.
- Subject agrees to be compliant with study requirements and adhere to post-operative dietary \& exercise recommendations for the duration of the study.
- Subjects between the ages of 22-65 years.
- History or failure with non-surgical weight-loss methods.
- If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
Key exclusion criteria (28 listed)
- History of or intra-operative evidence of prior bariatric, gastric or esophageal surgery.
- Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.
- Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
- Large hiatal hernia (>3 cm) by history or as determined by pre-enrollment endoscopy.
- Pancreatic insufficiency/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 |
|---|---|---|
| POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture AnchorsPOSE2.0 (g-Cath EZ snowshoe suture anchors placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program | Device | Treatment |
Primary outcome
Percentage of total body weight loss (%TBWL) following randomization
Time frame: 12 months
To be deemed effective, the difference in %TBWL between the treatment group minus the control group must be significantly greater than 5%.
Responder rate of at least 50% in the POSE2.0 treatment group
Time frame: 12 months
Responder defined as >5% TBWL
Safety- Incidence of device and procedure related adverse events through 12 months
Time frame: 12 months
Incidence of device and procedure related adverse events through 12 months defined as Clavien-Dindo Class III or greater.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Barham Abu Dayyeh, MD, MPH principal investigator
Mayo Clinic
Erik Wilson, MD principal investigator
University of Texas Medical School at Houston
Questions about this trial
What is this clinical trial studying?
A study testing POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors in people with Obesity, run by USGI Medical.
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 10 inclusion and 28 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: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VP of Medical Affairs (949-369-3890, info@usgimedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of total body weight loss (%TBWL) following randomization (time frame: 12 months). The study lists 3 primary outcomes in all. 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 7 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.