Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study

NCT06272201 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 50620 TPR
• Study Type: interventional
• Target: 186
• Locations: 0 countries
• Sites: N/A

Brief 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, 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

Outcome Measures

Primary Outcomes (3)

• 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%.

  12 months

• Responder rate of at least 50% in the POSE2.0 treatment group

  Responder defined as \>5% TBWL

  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.

  12 months

Study Arms (2)

Treatment

EXPERIMENTAL

POSE2.0 Treatment with Lifestyle Modification

Device: POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors

Control

NO INTERVENTION

Lifestyle Modification alone

Interventions

POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors DEVICE

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

Treatment

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• USGI Medical: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barham Abu Dayyeh, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Erik Wilson, MD

  University of Texas Medical School at Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VP of Medical Affairs

CONTACT

949-369-3890; info@usgimedical.com

Director, RA/QA

CONTACT

949-369-3890; tpalmer@usgimedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 22, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share