Transoral Incisionless Fundoplication (TIF) for Laryngopharyngeal Reflux (LPR) Patients (TIF-LPR)

December 13, 2023 updated by: Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital
In this research study the investigators want to learn more about the effectiveness of an endoscopic procedure (an endoscope is a lighted tube that is placed down the participants esophagus, through the participants mouth) which uses a device that allows the doctor to repair or recreate the body's natural barrier to reflux. It uses preloaded forceps (tweezers) and fasteners and requires no incision to tighten the connection between the participants esophagus and stomach. This procedure is performed to aid in the treatment of symptoms of Gastroesophageal Reflux disease (GERD) in patients with diagnosed Laryngopharyngeal reflux (LPR). LPR is a condition resulting from backflow of stomach contents into the laryngopharynx (connection point in the participants throat through which food, water, and air pass) resulting in symptoms that can be referred to larynx/hypopharynx. The device the investigators will use to perform the transoral incisionless fundoplication procedure (TIF) is called the EsophyX device. The participants have been asked to participate because they have been diagnosed with LPR and have either failed medical therapy (taking prescription proton pump inhibitors (PPI) to reduce stomach acid production or do not want to be on long-term medical treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

To date, more than one-third of the motility patients that the investigators see in practice at Brigham and Women's Hospital have LPR. There is currently limited literature available addressing LPR as a primary indication for the TIF procedure moreover there is no single therapy that has proved its efficacy over the years against LPR. The investigators propose a pilot study to investigate the efficacy of TIF with the EsophyX device (EndoGastric Solutions, Inc., Redmond WA, USA) in patients with LPR. The study design would include up to 25 patients to receive the TIF procedure and will take 12 months to complete it. The investigators will compare objective and subjective outcomes at baseline and 3 months post TIF procedure to assess its efficacy against LPR. The investigators will submit the proposal to EndoGastric solutions, anticipating that they will cover part of the funding required to conduct our Pilot Study.

In conclusion, LPR lacks an effective therapy despite posing a significant healthcare burden. Medical therapy with PPI has a variable response, and more invasive Laparoscopic fundoplication is associated with a high risk of unwanted long-term side effects. TIF can potentially bridge this gap between medical and more invasive approaches for the patient population suffering from this condition. It has the potential to prove to be a less invasive and safe treatment indication for patients with chronic or refractory LPR who have either failed medical therapy or do not want to be on long-term medical treatment.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Christopher C. Thompson, MD, MSc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with diagnosed Laryngopharyngeal reflux (LPR) who are scheduled for endoscopic transoral incisionless fundoplication procedure (TIF).

Description

Inclusion Criteria:

  • Any adult with a confirmed diagnosis of LPR with HEMII-pH (≥2 LPR events in 24 hr period), Esophageal manometry and Laryngoscopy.
  • Having daily bothersome symptoms of LPR.
  • Willing and able to cognitively sign a consent form for Surgical treatment of LPR with the TIF.
  • Willing and available for follow up visit and repeat testing (HEMII-pH, Esophageal manometry and laryngoscopy) at 3 months post procedure.

Exclusion Criteria:

  • Unable or unwilling to provide informed consent
  • Unable or unwilling to comply with study procedures
  • Body Mass Index >35.
  • Hiatal hernia>2cm in axial height and >2cm in greatest transverse dimension.
  • Esophagitis grade C and D
  • Barrett's esophagus>2cm
  • Esophageal ulcer
  • Fixed esophageal stricture or narrowing
  • Portal hypertension and/or varices
  • Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis
  • Gastroparesis
  • Coagulation disorders
  • History of any of the following: resective gastric or esophageal surgery, anti-reflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
  • Pregnancy or plans of pregnancy in the next 12 months
  • Enrollment in another device or drug study that may confound the results.
  • Acute or chronic illness or history of illness which in the opinion of the investigator could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data, such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes (HbA1c >12%), etc.
  • Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LPR Patients
Adults with a confirmed diagnosis of LPR with HEMII-pH (≥2 LPR events in 24 hr period), Esophageal manometry and Laryngoscopy undergoing endoscopic transoral incisionless fundoplication (TIF).
Device: Transoral Incisionless Fundoplication
Transoral incisionless fundoplication (TIF) is a minimally invasive, endoscopic fundoplication technique. Transoral Incisionless Fundoplication (TIF) is an FDA approved endoluminal fundoplication technique which utilizes EsophyX device to restore the valve at the gastroesophageal junction. The EsophyX device (EndoGastric Solutions, Redmond, Wash, USA) is an FDA approved procedure for chronic of refractory GERD.
Other Names:
  • TIF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LPR Symptoms
Time Frame: Baseline and 3 months post-procedure
Number of participants reporting LPR symptom elimination or clinically significant improvement evaluated by RSI (Reflux Symptom Index) and GERD-HRQL Questionnaire.
Baseline and 3 months post-procedure
LPR Events
Time Frame: Baseline and 3 months post-procedure
Number of participants with reduced LPR events as evaluated by HEMII-pH
Baseline and 3 months post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GERD Symptoms
Time Frame: Baseline and 3 months post-procedure
Elimination of Daily bothersome GERD symptoms evaluated by GERD-HRQL Questionnaire
Baseline and 3 months post-procedure
Patient Satisfaction
Time Frame: Baseline and 3 months post-procedure
Patients Satisfaction evaluated by GERD-HRQL Questionnaire
Baseline and 3 months post-procedure
Lower Esophageal Sphincter Tone
Time Frame: Baseline and 3 months post-procedure
Change in Lower esophageal sphincter tone evaluated by Esophageal manometry
Baseline and 3 months post-procedure
Laryngopharyngeal anatomy
Time Frame: Baseline and 3 months post-procedure
Change in Laryngopharyngeal anatomy evaluated by Laryngoscopy
Baseline and 3 months post-procedure
PPI Discontinuation
Time Frame: Baseline and 3 months post-procedure
Discontinuation of PPI's
Baseline and 3 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

EndoGastric Solutions

Investigators

  • Principal Investigator: Christopher C. Thompson, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P000144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan to share data will be on a case by case basis. The other researchers may contact the PI and discuss study plans. An agreement through Mass General Brigham will need to be executed prior to sharing the de-identified data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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