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Unnecessary test? study questions routine throat tube before reflux surgery

NCT ID NCT07659080

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study looks at whether people with acid reflux or a hiatal hernia can safely skip a test called esophageal manometry before their surgery. The test, which involves a thin tube through the nose to measure throat muscles, can be uncomfortable and delay surgery. Researchers will compare two groups of 96 adults: one group gets the test as usual, the other skips it. Everyone will have the same standard operation. The goal is to see if skipping the test leads to similar swallowing ability one year after surgery, while reducing discomfort and wait times.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If skipping manometry works as well as the standard approach, it could make preparing for acid reflux surgery faster, less uncomfortable, and cheaper.
What could go wrong
This is a small, early-stage study (96 people) comparing two preoperative procedures, not testing a new treatment. Results may not apply to everyone with GERD.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Age ≥ 18 years 2. Documented GERD and/or hiatal hernia (Type I, II, or small Type III) confirmed on EGD and/or imaging (i.e. CT scan or upper GI study) within 12 months 3. Presence of at least one guideline-based indication for antireflux surgery: 1. Typical GERD symptoms (heartburn and/or regurgitation) refractory to or recurrent after adequate PPI therapy 2. PPI-dependent GERD with patient preference for surgical management 3. Extra-esophageal GERD symptoms (chronic cough, laryngitis, asthma) with pathologic reflux confirmed on ambulatory pH study 4. Symptomatic Type II/III paraesophageal hernia (postprandial pain, early satiety, dysphagia to solids) 5. Objective documentation of pathologic esophageal acid exposure on ambulatory reflux monitoring (24-hour pH-impedance or 48-hour Bravo pH capsule) confirming GERD diagnosis, performed within 12 months of enrollment 4. Mellow-Pinkas dysphagia score = 0 at baseline (no overt dysphagia) 5. Eckardt score \< 1 (achalasia screening) 6. Ability to provide informed consent and comply with 12-month follow-up. Exclusion Criteria: 1. Overt dysphagia (Mellow-Pinkas ≥ 1 or Eckardt ≥ 1) 2. Prior esophageal or gastric surgery 3. Known or clinically suspected achalasia or primary motility disorder 4. Endoscopic stricture, mass, or luminal obstruction 5. Giant paraesophageal hernia (Type IV, or Type III with \>50% of stomach herniated intrathoracically) 6. Connective tissue disease with esophageal involvement (e.g., scleroderma/CREST) 7. Active esophageal or gastric malignancy 8. Pregnancy 9. BMI \> 40 kg/m² (patients with severe obesity who would be candidates for bariatric surgery should be referred for metabolic/bariatric evaluation, as per the multi-society GERD guideline recommending weight-loss surgery consideration in this population) 10. Participation in another interventional trial within 30 days 11. Prior esophageal manometry within 12 months demonstrating a major motility disorder (achalasia, absent contractility, distal esophageal spasm, hypercontractile esophagus); such patients should be managed per standard motility disorder pathways and are not candidates for this trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • St Joseph's Healthcare, McMaster University

    Hamilton, Ontario, L8N 4A6, Canada

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