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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Hillel Yaffe Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01167439
First received: July 21, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Dysphagia
Procedure: Upper esophageal sphincter myotomy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Dysphagia in Oculopharyngeal Muscular Dystrophy. Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up.

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Mild dysphagia
Active Comparator: Severe dysphagia Procedure: Upper esophageal sphincter myotomy
Upper esophageal sphincter release operation to allow better swallowing. The intervention is done under GA and by extra-mucosal approach.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • heterozygote and homozygote OPMD patients

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167439

Contacts
Contact: Sergiu C. Blumen, MD 972-4-630-4262

Locations
Israel
Israel National Center for OPMD and Dysphagia, HYMC Recruiting
POB 169, Hadera, Israel, 38100
Contact: Sergiu C. Blumen, MD    972-52-2645938    navabl@hotmail.com   
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Itzhak Bravermen, MD, Hillel Yaffe Medical Center, Hadera, Israel
ClinicalTrials.gov Identifier: NCT01167439     History of Changes
Other Study ID Numbers: 0027-09-HYMC
Study First Received: July 21, 2010
Last Updated: July 21, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hillel Yaffe Medical Center:
OPMD, dysphagia
Dysphagia severity
Nutritional state
Speech quality
Upper esophageal sphincter myotomy

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Muscular Dystrophies
Muscular Dystrophy, Oculopharyngeal

ClinicalTrials.gov processed this record on July 24, 2014