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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: Completed Phase 4 study, sponsored by Albany Medical College.
NCT03701919 is a Phase 4 study that has completed, run by Albany Medical College. The registered enrollment target is 84 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
We will sum the number of "as needed" doses of intravenous antiemetics required by patients in both the treatment arm and the control arm of the study
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 |
What the finished NCT03701919 record still lists
NCT03701919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Botulinum toxin pyloroplasty is the first listed.
NCT03701919 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03701919's enrollment target sits among peer trials
84 929th of 2000 higher than 1,064 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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