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NCT01515501 · ClinicalTrials.gov registry record · NA
Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial (EDGE Trial)
A NA study of Constipation and Hirschsprung Disease, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01515501: Completed NA study of Constipation and Hirschsprung Disease, sponsored by Massachusetts General Hospital.
NCT01515501 is a NA study of Constipation and Hirschsprung Disease that has completed, run by Massachusetts General Hospital. The registered enrollment target is 12 participants, below the 205-participant average among 54 other Constipation trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01515501, a NA study of Constipation and Hirschsprung Disease, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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 including clinical history, Bristol stool scale, anorectal manometry results, and SITZ marker studies. Cost and recovery time will be compared.
Primary Outcome
The adequacy of the tissue specimen, the proportion of diagnostic specimens, and the proportion of patients that would have required subsequent referral for full thickness biopsy, will be compared. Variable such as cost and recovery time will be compared. Biopsy results will be compared with patient's pre-endoscopy clinical data including their history of constipation, results of SITZ marker studies, Bristol stool scale, and anorectal manometry.
Conditions Studied
Interventions
- PROCEDURE Endoscopic mucosal resection (EMR)
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-10 |
| Est. Completion | 2018-08 |
| Phase | NA |
What the finished NCT01515501 record still lists
NCT01515501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 205-participant average among 54 other Constipation trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Constipation appearing as the primary indexed condition, and to 1 intervention - of which Endoscopic mucosal resection (EMR) is the first listed.
NCT01515501 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01515501 about?
NCT01515501 is a clinical study titled "Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial (EDGE Trial)". 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 including clinical history, Bristol stool scale, anorectal manometry results, and SITZ marker studie...
What is the current status of trial NCT01515501?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2007-10. Estimated completion is 2018-08.
What conditions does trial NCT01515501 study?
This clinical trial studies the following conditions: Constipation, Hirschsprung Disease.
What interventions are being tested in trial NCT01515501?
The interventions under investigation include: Endoscopic mucosal resection (EMR) (PROCEDURE).
Who is sponsoring clinical trial NCT01515501?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01515501 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Constipation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01515501's enrollment target sits among peer trials
12 51st of 54 higher than 3 of 54 other Constipation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Constipation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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