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NCT03649451
Reference Dose Levels During Fluoroscopically Guided Procedures in Operating Rooms
trial in Radiation Exposure in 8,840 participants. Completed in 30 August 2019.
30 March 2019
Quick facts
| Lead sponsor | Societe Francaise de Physique Medicale |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 8,840 |
| Start date | 3 September 2018 |
| Primary completion | 30 March 2019 |
| Estimated completion | 30 August 2019 |
| Sites | 1 location across France |
Conditions studied
- Radiation Exposure — all drugs for Radiation Exposure →
Sponsor
Societe Francaise de Physique Medicale
Who can join
Adults 16 to 100, any sex, with Radiation Exposure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is conducted by a working group of the French Society of Medical Physics (SFPM). Its main aim is to establish reference dose levels for the most common procedures performed in operating rooms using mobile X-ray systems, hence helping medical physicists and surgeons to evaluate their practice and optimize patient radiation protection. This is a multi-centric prospective study involving 73 medical institutions of different categories (public university hospitals, clinics, centers dedicated to cancer treatment, etc.). It consists on progressively collecting anonymous data for 15 to 30 procedures from a list of 62 types of procedures, belonging to 7 surgery specialties (neurosurgery, orthopedic surgery, digestive surgery, urology, cardiology, vascular surgery and multi-specialty). Collected data include patient BMI and information about the X-ray equipment, the medical procedure and the dosimetric parameters. Data collection doesn't require the access to the patient medical record and doesn't impact his medical care. Proposed dose reference levels will be expressed in terms of KAP (Kerma-Area-Product), fluoroscopy time and air Kerma. Moreover, multiple statistical analyses will be done to investigate the impact of different variables on the procedure X-ray doses.
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 NCT03649451
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03649451 (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 Societe Francaise de Physique Medicale
- Last refreshed: 13 May 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/NCT03649451.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing