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NCT04489680
Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.
NA trial testing Educational in Cleft Palate Lip in 26 participants. Completed in 31 August 2019.
30 April 2019
Quick facts
| Lead sponsor | Guy's and St Thomas' NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 26 |
| Start date | 1 January 2019 |
| Primary completion | 30 April 2019 |
| Estimated completion | 31 August 2019 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Educational
Conditions studied
- Cleft Palate Lip — all drugs for Cleft Palate Lip →
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Who can join
Eligibility, any sex, with Cleft Palate Lip. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Trainees' experience in cleft surgery is limited due to the high-risk nature of the surgery and centralization of cleft care. Simulations allow trainees to learn complex surgical skills whilst ensuring patient safety. Existing cleft surgical simulators are over-simplified or prohibitively expensive. We developed and tested a high-fidelity yet cost-effective simulator for cleft palate repair. Skeletal elements were obtained through high-resolution scanning of a pathologic specimen, 3D printed and then molded in plastic. Soft tissue components were formed through molding layers of silicone. 26 UK specialty trainees performed a vomerine mucosal flap and intra-velar veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires assessing cleft knowledge and surgical confidence were compared for statistical significance.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04489680
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Guy's and St Thomas' NHS Foundation Trust trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04489680 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Guy's and St Thomas' NHS Foundation Trust
- Last refreshed: 28 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04489680.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing