DysphagiaPhase 1OPMDNCT01167439

Dysphagia in Oculopharyngeal Muscular Dystrophy (OPMD)- Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up

A Phase 1 study testing Upper esophageal sphincter myotomy in people with Dysphagia, run by Hillel Yaffe Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The investigators aimed to review the natural history of dysphagia and dysphonia in OPMD in order to identify the best candidates and the proper timing to perform dysphagia alleviating procedures in both heterozygote and homozygote patients from the large pool of cases with this disease in Israel. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Dysphagia
What is being tested?: Upper esophageal sphincter myotomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteIsrael
Study dates: Jul 2009to Jul 2011
Phase: Phase 1
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

heterozygote and homozygote OPMD patients

Who cannot join

Trial locations and contacts

1 site in 1 country.

Sergiu C. Blumen, MD contact

972-4-630-4262

Israel1 site, 1 recruiting

Israel National Center for OPMD and Dysphagia, HYMC
POB 169, Hadera, 38100
Sergiu C. Blumen, MD, 972-52-2645938, navabl@hotmail.com
Recruiting

Other trials in Israel

About this study

Official title: Dysphagia in Oculopharyngeal Muscular Dystrophy. Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up.

Read the detailed description

Clinical evaluation of patients suspected of having OPMD. Genetic confirmatory tests (diagnostic DNA test) at the genetic unit in Afula Hospital. Clinical follow-up with endoscopic fiber optic evaluation of swallowing. Pre-operative assessment. Crycopharyngeal myotomy intervention in selected patients. Nutrition follow-up.

Conditions: Dysphagia
Being tested: Upper esophageal sphincter myotomy
Keywords: OPMD, dysphagia, Dysphagia severity, Nutritional state, Speech quality, Upper esophageal sphincter myotomy
Medical subject headings: Deglutition Disorders, Muscular Dystrophy, Oculopharyngeal

What participants receive

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

Upper esophageal sphincter myotomyProcedure or surgery
Upper esophageal sphincter release operation to allow better swallowing. The intervention is done under GA and by extra-mucosal approach.

Study groups in NCT01167439
Study group	Role	What they receive
Mild dysphagia	No intervention	Not described
Severe dysphagia	Active comparator	Not described Receives: Procedure: Upper esophageal sphincter myotomy

What is being measured

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

Dysphagia, quality of life. Proper intervention timing in OPMD based on knowledge about the natural history of the feeding difficulty.
Dysphagia, quality of life. Proper intervention timing in OPMD patients is very important and must be based on deep knowledge about the natural history of the feeding difficulty.
Measured: at least 3 years

Timeline

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

Jul 2009Jul 2011

First posted22 Jul 2010 (estimated)
Study startJul 2009
Primary completionJul 2011 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DysphagiaStudies of the same condition, open and under way.
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 1
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01167439
Sponsor's protocol ID: 0027-09-HYMC
Acronym: OPMD
Status last verified: Dec 2009
First submitted: 21 Jul 2010
Last updated: 22 Jul 2010
Results posted: No
Data monitoring committee: No

Want to know more?

Sergiu C. Blumen, MD

972-4-630-4262

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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All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dysphagia in Oculopharyngeal Muscular Dystrophy. Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up.
ClinicalTrials.gov ID: NCT01167439
Acronym / sponsor ID: OPMD / 0027-09-HYMC
Conditions: Dysphagia
Keywords: OPMD, dysphagia, Dysphagia severity, Nutritional state, Speech quality, Upper esophageal sphincter myotomy
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Hillel Yaffe Medical CenterOther government
Study start: Jul 2009
Primary completion: Jul 2011 (estimated)
First posted: 22 Jul 2010 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mild dysphagia	No intervention	–
Severe dysphagia	Active comparator	Procedure: Upper esophageal sphincter myotomy

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

heterozygote and homozygote OPMD patients

Key exclusion criteria (1 listed)

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
Upper esophageal sphincter myotomyUpper esophageal sphincter release operation to allow better swallowing. The intervention is done under GA and by extra-mucosal approach.	Procedure or surgery	Severe dysphagia

Primary outcome

Dysphagia, quality of life. Proper intervention timing in OPMD based on knowledge about the natural history of the feeding difficulty.
Time frame: at least 3 years
Dysphagia, quality of life. Proper intervention timing in OPMD patients is very important and must be based on deep knowledge about the natural history of the feeding difficulty.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2010.

Related trials for Dysphagia

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
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
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux

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.

Sergiu C. Blumen, MD contact

972-4-630-4262

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Upper esophageal sphincter myotomy in people with Dysphagia, run by Hillel Yaffe Medical Center at 1 site in Israel.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Jul 2010. 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 Israel. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Sergiu C. Blumen, MD (972-4-630-4262), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dysphagia, quality of life. Proper intervention timing in OPMD based on knowledge about the natural history of the feeding difficulty. (time frame: at least 3 years). 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 NCT01167439.

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 22 Jul 2010.