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NCT01664806 · ClinicalTrials.gov registry record · Phase 3
Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin
A Phase 3 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT01664806 is a Phase 3 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 40 participants.
The verdict
NCT01664806, a Phase 3 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study Summary
Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy operation. The appearance of burns are common following laparoscopic cholecystectomy; particularly at the port site of the active electrode. Willson et al found that 9 out of 19 skin biopsies from the skin adjacent to the port site of the monopolar instrument's active electrode were found to have thermal injury by histology. \[Willson et al. Surg Endosc (1997) 11:653\] Authors have speculated that using different generator modes may lead to less capacitive coupling; \[Wu et al Am J Surg (2000) 179: 67\] although no data exists to support these speculations. The investigators hypothesize that capacitive coupling electrosurgical injuries from monopolar instruments are occurring during laparoscopic cholecystectomy operations. The investigators hypothesize that use of blend modes will reduce the incidence of capacitive coupling thermal injuries during laparoscopic operations in comparison to coag modes.
Interventions
- DEVICE Covidien Triad monopolar generator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01664806
The ClinicalTrials.gov registry entry for NCT01664806 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Covidien Triad monopolar generator is the first listed.
NCT01664806 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01664806 about?
NCT01664806 is a clinical study titled "Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin". Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy operation. The appearance of burns are common following laparoscopic cholecystectomy; particularly at the port site of the active electrode. Willson et al found that 9 out of 19 skin biopsies from the skin adjacent t...
What is the current status of trial NCT01664806?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2010-11. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01664806?
The interventions under investigation include: Covidien Triad monopolar generator (DEVICE).
Who is sponsoring clinical trial NCT01664806?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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