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Transoral Fundoplication Prior to Sleeve Gastrectomy Versus RNY Gastric Bypass on GERD Symptoms in Bariatric Patients
NCT05365087 · View on ClinicalTrials.gov ↗
Study Summary
A retrospective and prospective cohort study to compare the effect of completing a Transoral Fundoplication procedure prior to Laparoscopic Sleeve Gastrectomy surgery to Laparoscopic Roux-en-Y Gastric Bypass in bariatric patients with Gastroesophageal Reflux Disease signs and symptoms. The aim of this study is to examine the effect of TF prior to sleeve gastrectomy as compared to Roux-en-Y Gastric Bypass on reflux symptoms in bariatric patients. Additional Follow up data until 10 years will be collected to evaluate for sequelae of GERD.
Conditions Studied
Interventions
- PROCEDURE Transoral Fundoplication and Sleeve Gastrectomy
- PROCEDURE Gastric Bypass
Study Locations (1)
South Carolina
- Lexington Health Incorporated — West Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2032-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05365087
The ClinicalTrials.gov registry entry for NCT05365087 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lexington Health Incorporated, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 2 interventions — of which Transoral Fundoplication and Sleeve Gastrectomy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05365087 reports 1 study location spanning 1 distinct geographic area — top geographies include South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05365087 about?
NCT05365087 is a clinical study titled "Transoral Fundoplication Prior to Sleeve Gastrectomy Versus RNY Gastric Bypass on GERD Symptoms in Bariatric Patients". A retrospective and prospective cohort study to compare the effect of completing a Transoral Fundoplication procedure prior to Laparoscopic Sleeve Gastrectomy surgery to Laparoscopic Roux-en-Y Gastric Bypass in bariatric patients with Gastroesophageal Reflux Disease signs and symptoms. The aim of th...
What is the current status of trial NCT05365087?
This trial is currently active not recruiting. The enrollment target is 180 participants. The study started on 2018-03-01. Estimated completion is 2032-12-31.
What conditions does trial NCT05365087 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05365087?
The interventions under investigation include: Transoral Fundoplication and Sleeve Gastrectomy (PROCEDURE), Gastric Bypass (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05365087?
This trial is sponsored by Lexington Health Incorporated, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05365087 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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