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NCT03847636 · ClinicalTrials.gov registry record · NA
CryoBalloon Ablation for Treatment of Duodenal Adenomas
A NA study of Familial Adenomatous Polyposis and Duodenal Adenomas, sponsored by Johns Hopkins University.
- Active
- Registry status
- NA
- Development phase
- 44
- Enrollment target
- 4
- Study locations
NCT03847636: Active NA study of Familial Adenomatous Polyposis and Duodenal Adenomas, sponsored by Johns Hopkins University.
NCT03847636 is a NA study of Familial Adenomatous Polyposis and Duodenal Adenomas that is active but no longer recruiting, run by Johns Hopkins University. The registered enrollment target is 44 participants, below the 244-participant average among 10 other Familial Adenomatous Polyposis trials with a reported enrollment target (82% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03847636, a NA study of Familial Adenomatous Polyposis and Duodenal Adenomas, is active but no longer recruiting, sponsored by Johns Hopkins University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
- 4
- Study locations
Study Summary
This multicenter prospective non-randomized interventional study (clinical trial) that will assess the safety and efficacy of cryoballoon ablation treatment using the C2 Cryoballoon device (Pentax Medical Corporation) as an alternative primary treatment modality for sporadic and familial nonampullary nonpolypoid (flat) duodenal adenomas.
Primary Outcome
To assess participants with any adverse event following cryoablation using the C2 cryoballoon system (per patient analysis). This includes serious adverse events (hospitalization, emergency room visit, bleeding requiring intervention) and post-procedure upper abdominal pain, nausea and gas-bloat
Conditions Studied
Interventions
- DEVICE CryoBalloon ablation
Study Locations (4)
Maryland
- Johns Hopkins Hospital - Baltimore
New York
- Northwell Health - Manhasset
Pennsylvania
- Geisinger Medical Center - Danville
Texas
- Methodist Dallas Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2019-05-13 |
| Est. Completion | 2026-03 |
| Phase | NA |
What the registry record for NCT03847636 still lists
NCT03847636 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 244-participant average among 10 other Familial Adenomatous Polyposis trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Familial Adenomatous Polyposis appearing as the primary indexed condition, and to 1 intervention - of which CryoBalloon ablation is the first listed.
NCT03847636 reports a single indexed study location in Maryland, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03847636 about?
NCT03847636 is a clinical study titled "CryoBalloon Ablation for Treatment of Duodenal Adenomas". This multicenter prospective non-randomized interventional study (clinical trial) that will assess the safety and efficacy of cryoballoon ablation treatment using the C2 Cryoballoon device (Pentax Medical Corporation) as an alternative primary treatment modality for sporadic and familial nonampullar...
What is the current status of trial NCT03847636?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 44 participants. The study started on 2019-05-13. Estimated completion is 2026-03.
What conditions does trial NCT03847636 study?
This clinical trial studies the following conditions: Familial Adenomatous Polyposis, Duodenal Adenomas.
What interventions are being tested in trial NCT03847636?
The interventions under investigation include: CryoBalloon ablation (DEVICE).
Who is sponsoring clinical trial NCT03847636?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03847636 being conducted?
This trial has 4 study locations across Maryland, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03847636's enrollment target sits among peer trials
44 5th of 10 higher than 5 of 10 other Familial Adenomatous Polyposis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Familial Adenomatous Polyposis 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.
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