Gastric Emptying Using Two Imaging Methods for Those Who Have Undergone POSE2 Weight Loss Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-16

Study Completion Date

2020-11-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare a less invasive breath test against the current standard for assessing gastric (stomach) emptying. The current standard of care is a procedure called Nuclear Scintigraphy of a Solid Meal (NSSM). This study will compare this method to a Gastric Emptying Breath Test (GEBT).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endoscopic Gastric Plication Using the POSE2.0 Technique for Management of Fatty Liver Disease

NCT05611567

Non-Alcoholic Fatty Liver Disease Obesity

COMPLETED NA

Endoscopic Suturing of the Gastric Pylorus to Delay Gastric Emptying and Treat Obesity

NCT02191501

Obesity Over Weight

TERMINATED NA

Gastric Ultrasound in Patients Who Have Undergone Bariatric Surgery

NCT07310875

Obesity Weight Loss Gastrectomy

NOT_YET_RECRUITING NA

A Study of Sleeve Gastrectomy Risks and Benefits

NCT06075511

Renal Failure

WITHDRAWN

Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) as a Treatment for Obesity

NCT05713071

Obesity Weight Loss Delayed Gastric Emptying Following Procedure +3 more

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Weight Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observational

NSSM and GEBT

Intervention Type OTHER

The time to half gastric emptying (T1/2) will be assessed via Gastric Emptying Breath Tests (GEBT) and Nuclear Scintigraphy of a Solid Meal (NSSM) at baseline, 2 months, and 6 months. This data will be collected from seven adult subjects, with obesity, who have recently received Endoscopic Bariatric and Metabolic Therapy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NSSM and GEBT

The time to half gastric emptying (T1/2) will be assessed via Gastric Emptying Breath Tests (GEBT) and Nuclear Scintigraphy of a Solid Meal (NSSM) at baseline, 2 months, and 6 months. This data will be collected from seven adult subjects, with obesity, who have recently received Endoscopic Bariatric and Metabolic Therapy.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects must be 22-65 years of age at time of enrollment
* Subjects must already be consented to 17-007934 or 19-001254
* Subject must be agreeable and compliant with study requirements, including up to three (baseline, 2 month, and 6 month) visits, as well as undergoing GEBT and NSSM testing.
* If female, must be post-menopausal, surgically sterile, or agree to practice a form of birth control or abstinence during year of study and have negative serum HCG at screening/baseline
* Must be willing and able to travel, as needed, to the Investigator's office to complete all routine follow-up visits

Exclusion Criteria

* Persons presently or soon to be incarcerated
* Females who are pregnant or suspect they may be pregnant
* Persons with nicotine and/or alcohol dependence
* Patients with cognitive impairment that limits their ability to make autonomous decisions
* Known allergies or sensitivities to study materials (eggs and spirulina)
* Assessed, by the physician or delegate, that enrollment would not be appropriate

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No