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
Recruitment status was Recruiting
Sponsor:
Hillel Yaffe Medical Center
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
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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
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 Muscular Dystrophies Muscular Dystrophy, Oculopharyngeal 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 |
ClinicalTrials.gov processed this record on May 21, 2013