|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00671684 |
|
Date of registration:
|
01/05/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease
EDGE |
|
Scientific title:
|
Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial |
|
Date of first enrolment:
|
October 2007 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Enrolling by invitation |
|
URL:
|
http://clinicaltrials.gov/show/NCT00671684 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Braden Kuo, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
MGH |
|
|
Name:
|
Clarissa Foy, NP |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
MGH |
|
|
Name:
|
Field F Willingham, MD, MPH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
MGH |
|
|
Name:
|
Garrett C Zella, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
MGH |
|
|
Name:
|
Leonel Rodriguez, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
MGH |
|
|
Name:
|
Mari Mino-Kenudson, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
MGH |
|
|
Name:
|
William R Brugge, MD, FASGE |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
MGH |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients offered a rectal suction biopsy
Exclusion Criteria:
- any contraindication to general anesthesia or conscious sedation
- contraindication to endoscopy
- untreated or unmanageable coaguloapathy
- thrombocytopenia (<50)
- inability to provide informed consent.
Age minimum:
10 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Constipation
|
|
Hirschsprung's Disease
|
|
Intervention(s)
|
|
Procedure: Endoscopic Mucosal Resection (EMR)
|
|
Primary Outcome(s)
|
|
The major goal of this study is to test the hypothesis that EMR will result in a higher proportion of diagnostic specimens than RSB in patients sent for rectal suction biopsy.
[Time Frame: April 2009]
|
|
Secondary Outcome(s)
|
|
Secondary outcome variables include the size of the specimen, the presence of ganglionic tissue, the presence of submucosal tissue, and the positivity of the acetylcholinesterase stain.
[Time Frame: April 2009]
|
|
Secondary ID(s)
|
|
2007P001577
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|