Status:
COMPLETED
Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial (EDGE Trial)
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Constipation
Hirschsprung Disease
Eligibility:
All Genders
10+ years
Phase:
NA
Brief Summary
Patients undergoing routine rectal suction biopsy will undergo as part of the study an additional Endoscopic mucosal resection. The biopsy results will also be correlated with patient's clinical data ...
Detailed Description
Background: Adult and pediatric patients presenting with chronic constipation and/or motility disorders may be referred for rectal biopsy to rule out aganglionosis or Hirschsprung's disease. The tradi...
Eligibility Criteria
Inclusion
- 10 years of age or older
- offered Rectal Suction biopsy
Exclusion
- any contraindication to general anesthesia or conscious sedation
- contraindication to endoscopy
- untreated or unmanageable coagulopathy
- thrombocytopenia (\<50)
- inability to provide informed consent.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01515501
Start Date
October 1 2007
End Date
August 1 2018
Last Update
August 16 2018
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114