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COMPLETED NA

Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study

NCT01136980 · View on ClinicalTrials.gov ↗

Study Summary

The objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal consensus definition while on PPIs compared with sham and placebo controls.

Interventions

  • DEVICE TIF Transoral Fundoplication
  • OTHER Sham placebo procedure

Study Locations (9)

Oregon

  • The Oregon Clinic — Portland
  • Oregon Health and Science University — Portland

California

  • Cedars Sinai Medical Center — Los Angeles

Colorado

  • SurgOne PC — Englewood

Illinois

  • Northwestern University — Chicago

Ohio

  • Ohio State University Hospital — Columbus

Texas

  • University of Texas, Health Science Center at Houston — Houston

Virginia

  • Reston Surgical Associates — Reston

Washington

  • University of Washington — Seattle

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2011-04
Est. Completion 2018-03
Phase NA

Sponsor

EndoGastric Solutions

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01136980

The ClinicalTrials.gov registry entry for NCT01136980 describes a study currently listed as completed. It is categorized as NA, 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 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EndoGastric Solutions, 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 2 conditions, with Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 2 interventions — of which TIF Transoral Fundoplication 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: NCT01136980 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Oregon, California, Colorado. 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 NCT01136980 about?

NCT01136980 is a clinical study titled "Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study". The objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal consensus definition while on PPIs compared with sham and placebo control...

What is the current status of trial NCT01136980?

This trial is currently completed. It is a NA study. The enrollment target is 129 participants. The study started on 2011-04. Estimated completion is 2018-03.

What conditions does trial NCT01136980 study?

This clinical trial studies the following conditions: Gastroesophageal Reflux Disease, Hiatal Hernia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01136980?

The interventions under investigation include: TIF Transoral Fundoplication (DEVICE), Sham placebo procedure (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01136980?

This trial is sponsored by EndoGastric Solutions, 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 NCT01136980 being conducted?

This trial has 9 study locations across California, Colorado, Illinois, Ohio, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial