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

NCT ID: NCT01167439

Last Updated: 2010-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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

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Dysphagia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mild dysphagia

Group Type NO_INTERVENTION

No interventions assigned to this group

Severe dysphagia

Group Type ACTIVE_COMPARATOR

Upper esophageal sphincter myotomy

Intervention Type PROCEDURE

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

Interventions

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Upper esophageal sphincter myotomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* heterozygote and homozygote OPMD patients

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hillel Yaffe Medical Center, Hadera, Israel

Locations

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Israel National Center for OPMD and Dysphagia, HYMC

POB 169, Hadera, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Sergiu C. Blumen, MD

Role: CONTACT

972-4-630-4262

Facility Contacts

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Sergiu C. Blumen, MD

Role: primary

972-52-2645938

Other Identifiers

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0027-09-HYMC

Identifier Type: -

Identifier Source: org_study_id

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