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NCT03701919 · ClinicalTrials.gov registry record · Phase 4
Botulinum Toxin Pyloroplasty to Reduce Postoperative Nausea and Vomiting After Sleeve Gastrectomy
A Phase 4 study, sponsored by Albany Medical College.
- Completed
- Registry status
- Phase 4
- Development phase
- 84
- Enrollment target
NCT03701919 is a Phase 4 study that has completed, run by Albany Medical College. The registered enrollment target is 84 participants.
The verdict
NCT03701919, a Phase 4 study, has completed, sponsored by Albany Medical College.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 84 participants
- Enrollment target
Study Summary
A common problem following sleeve gastrectomy surgery is called postoperative nausea and vomiting (PONV). This problem is uncomfortable for patients, and can also lead to other complications, including pneumonia. It is unclear what exactly causes this problem, but it may be partly caused by slow emptying of the stomach. The current treatments for PONV include medications, but these may only treat the symptoms. Botulinum toxin (BTX, brand name Botox®), produced naturally by the bacterium Clostridium botulinum and adapted for medical use, is an neurotransmitter inhibitor of the neuromuscular junction, and produces temporary muscular paralysis. BTX is widely used in cosmetic and other medical applications. Injecting BTX into the pylorus, which is the circular sphincter muscle at the end of the stomach, temporarily paralyzes the muscle, leaving it wide open, and allowing stomach contents to flow through. This effect lasts for several weeks, and then goes away. This may help prevent PONV.
Interventions
- DRUG Botulinum toxin pyloroplasty
- DRUG Normal saline pyloric injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2019-01-07 |
| Est. Completion | 2022-11-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03701919
The ClinicalTrials.gov registry entry for NCT03701919 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albany Medical College, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Botulinum toxin pyloroplasty is the first listed.
NCT03701919 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03701919 about?
NCT03701919 is a clinical study titled "Botulinum Toxin Pyloroplasty to Reduce Postoperative Nausea and Vomiting After Sleeve Gastrectomy". A common problem following sleeve gastrectomy surgery is called postoperative nausea and vomiting (PONV). This problem is uncomfortable for patients, and can also lead to other complications, including pneumonia. It is unclear what exactly causes this problem, but it may be partly caused by slow emp...
What is the current status of trial NCT03701919?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 84 participants. The study started on 2019-01-07. Estimated completion is 2022-11-11.
What interventions are being tested in trial NCT03701919?
The interventions under investigation include: Botulinum toxin pyloroplasty (DRUG), Normal saline pyloric injection (DRUG).
Who is sponsoring clinical trial NCT03701919?
This trial is sponsored by Albany Medical College, which has 52 total clinical trials registered on ClinicalTrials.gov.
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