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NCT04121338 · ClinicalTrials.gov registry record · Phase 1
Temporary Celiac Ganglion Block as a Test Before Celiac Ganglion Resection for Dysautonomia-Related Bowel Dysmotility
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT04121338: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT04121338 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04121338, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Dysautonomia is malfunction of the autonomic nervous system. It usually results from overactivity of the sympathetic portion and over-secretion of acetylcholine. Symptoms depend on the organ involved by this sympathetic overstimulation. Involvement of the gastrointestinal system results in chronic dysmotility, nausea, vomiting, food intolerance, weight loss and need for feeding tube placement and/or parenteral feeding. Autonomic celiac ganglia resection has been shown to alleviate symptoms as it interrupts the sympathetic stimulation to the gastrointestinal (GI) system, however there is no pre surgery test to confirm the diagnosis. The investigators' objective is to temporarily block the celiac ganglion with a long acting anesthetic (liposomal bupivacaine). If symptoms abate the diagnosis is confirmed and patient will proceed to surgery.
Interventions
- DRUG Liposomal bupivacaine
- PROCEDURE Celiac ganglion block
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-12-09 |
| Est. Completion | 2021-05-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04121338
The ClinicalTrials.gov registry entry for NCT04121338 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Liposomal bupivacaine is the first listed.
NCT04121338 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04121338 about?
NCT04121338 is a clinical study titled "Temporary Celiac Ganglion Block as a Test Before Celiac Ganglion Resection for Dysautonomia-Related Bowel Dysmotility". Dysautonomia is malfunction of the autonomic nervous system. It usually results from overactivity of the sympathetic portion and over-secretion of acetylcholine. Symptoms depend on the organ involved by this sympathetic overstimulation. Involvement of the gastrointestinal system results in chronic d...
What is the current status of trial NCT04121338?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2019-12-09. Estimated completion is 2021-05-15.
What interventions are being tested in trial NCT04121338?
The interventions under investigation include: Liposomal bupivacaine (DRUG), Celiac ganglion block (PROCEDURE).
Who is sponsoring clinical trial NCT04121338?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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