DysphagiaNCT01284894

Esophageal High Resolution Manometry and Dysphagia

A study testing Conventional manometry and High resolution manometry in people with Dysphagia, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Dysphagia
What is being tested?: Conventional manometry and High resolution manometry
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 247 participants
Where: 1 siteFrance
Study dates: Feb 2011to Dec 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female older than 18 years
Patient with unexplained dysphagia
Patient without cause of dysphagia on eso-gastro-duodenal endoscopy
Patient referred for esophageal manometry
Patient with health insurance
Informed consent signed

Who cannot join

Patient younger than 18 years
Allergy to one component of manometry catheter
Drug intake which can modify the esophageal motricity within 12 hours preceding the realization of the manometry
Patient unable to give his consent or legally incompetent
Patient non qualified according to the investigator
Patient refusal or absence of informed consent signed
Concomitant participation to another study

Trial locations and contacts

1 site in 1 country.

France1 site

Unité d'Exploration Fonctionnelle Digestive - Hopital Edouard Herriot - 69437 LYON Cedex 03
Lyon, Lyon, 69437

Other trials in France

About this study

Official title: Diagnostic Yield of Esophageal High Resolution Manometry in Patients With Unexplained Dysphagia

Two to 15% of subjects present dysphagia. In case of normal eso-gastro-duodenal endoscopy, patients with dysphagia are referred for esophageal motility testing. Esophageal manometry is the gold standard to evaluate esophageal motility in absence of esophageal obstruction. Two different techniques are available: the conventional manometry and the high resolution manometry. The second one may improve the diagnostic yield and the tolerance of examination in patients with dysphagia.

Conditions: Dysphagia
Being tested: Conventional manometry, High resolution manometry
Keywords: Dysphagia, Conventional manometry, High resolution manometry
Medical subject headings: Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Conventional manometryDevice
Conventional esophageal manometry
High resolution manometryDevice
High resolution esophageal manometry

Study groups in NCT01284894
Study group	Role	What they receive
Conventional manometry	Other	Not described Receives: Device: Conventional manometry
High resolution manometry	Experimental	Not described Receives: Device: High resolution manometry

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of patients correctly diagnosed for esophageal motility disorder
Measured: 6 months

Secondary outcomes (3)

Tolerability (pain, nausea, cough, anxiety) and side effects (nasal bleeding, vomiting, inhalation, esophageal perforation, cardiac failure)
Measured: 24 hours
Duration of examination and study analysis
Measured: day 0
Cost of patient care within the 6 months following the manometry
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Dec 2013

First posted27 Jan 2011 (estimated)
Study startFeb 2011
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DysphagiaStudies of the same condition, open and under way.
More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01284894
Sponsor's protocol ID: 2010.624/28
Status last verified: Dec 2025
First submitted: 26 Jan 2011
Last updated: 19 Dec 2025
Results posted: No
Data monitoring committee: No

Publications

Roman S, Huot L, Zerbib F, Bruley des Varannes S, Gourcerol G, Coffin B, Ropert A, Roux A, Mion F. High-Resolution Manometry Improves the Diagnosis of Esophageal Motility Disorders in Patients With Dysphagia: A Randomized Multicenter Study. Am J Gastroenterol. 2016 Mar;111(3):372-80. doi: 10.1038/ajg.2016.1. Epub 2016 Feb 2.
PubMed 26832656

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
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The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
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All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diagnostic Yield of Esophageal High Resolution Manometry in Patients With Unexplained Dysphagia
ClinicalTrials.gov ID: NCT01284894
Acronym / sponsor ID: 2010.624/28
Conditions: Dysphagia
Keywords: Dysphagia, Conventional manometry, High resolution manometry
Study type: Interventional
Recruitment status: Completed
Enrolment: 247 participants (actual)
Lead sponsor: Hospices Civils de LyonUniversity, hospital or other
Study start: Feb 2011
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 27 Jan 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Conventional manometry	Other	Device: Conventional manometry
High resolution manometry	Experimental	Device: High resolution manometry

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male or female older than 18 years
Patient with unexplained dysphagia
Patient without cause of dysphagia on eso-gastro-duodenal endoscopy
Patient referred for esophageal manometry
Patient with health insurance

Key exclusion criteria (7 listed)

Patient younger than 18 years
Allergy to one component of manometry catheter
Drug intake which can modify the esophageal motricity within 12 hours preceding the realization of the manometry
Patient unable to give his consent or legally incompetent
Patient non qualified according to the investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Conventional manometryConventional esophageal manometry	Device	Conventional manometry
High resolution manometryHigh resolution esophageal manometry	Device	High resolution manometry

Primary outcome

Percentage of patients correctly diagnosed for esophageal motility disorder
Time frame: 6 months

3 secondary outcomes

Tolerability (pain, nausea, cough, anxiety) and side effects (nasal bleeding, vomiting, inhalation, esophageal perforation, cardiac failure)
Time frame: 24 hours
Duration of examination and study analysis
Time frame: day 0
Cost of patient care within the 6 months following the manometry
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
Results publication: PubMed 26832656Roman S, Huot L, Zerbib F, Bruley des Varannes S, Gourcerol G, Coffin B, Ropert A, Roux A, Mion F. High-Resolution Manometry Improves the Diagnosis of Esophageal Motility Disorders in Patients With Dysphagia: A Randomized Multicenter Study. Am J Gastroenterol. 2016 Mar;111(3):372-80. doi: 10.1038/ajg.2016.1. Epub 2016 Feb 2.

Related trials for Dysphagia

Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Not yet recruiting
Standardizing Swallow Pressure Measurements
Dysphagia
Recruiting
The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
Nasopharyngeal Carcinoma (NPC)
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sabine ROMAN, Dr principal investigator

Unité d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - 69437 Lyon Cedex 03- France

Stanislas BRULEY DES VARANNES principal investigator

Service d'Hépato-Gastro-Entérologie - CHU Hôtel Dieu - Place A Ricordeau - 44093 Nantes Cedex - France

Franck ZERBIB principal investigator

Service d'Hépato-Gastro-Entérologie - Hôpital Saint-André - 33075 Bordeaux Cedex - France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Conventional manometry and High resolution manometry in people with Dysphagia, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients correctly diagnosed for esophageal motility disorder (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01284894, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.