Accidentology and Traumatology Associated With Foiling in... | NCT06680453

Studies
Accidentology and Traumatology Associated With Foiling in Brittany

NCT06680453

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Jun 12, 2026Actual

Enrollment

65Actual

Phase

Not provided

Conditions

Sport Injuries

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2025Actual

Primary Completion Date

Dec 18, 2025Actual

Completion Date

Feb 10, 2026Actual

First Submitted Date

Oct 16, 2024

First Submission Date that Met QC Criteria

Nov 6, 2024

First Posted Date

Nov 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2026

Last Update Posted Date

Jun 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In the 2010s, the practice of water sports was turned upside down by the arrival of a new discipline: foiling. The number of sailors, particularly amateurs, is increasing every every year. The foil offers greater speed and height, and has therefore the accidents and injuries that result. injuries. But there are very few studies on the subject. The TRAUMAF study proposes to compare the distribution of the number of patients injured during water sports with and without the use of foils. The study also looks at patient management and the type of injury. The aim is to anticipate the management of these patients during periods of practice of these sports.

Translated with DeepL.com (free version)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the importance of foil-equipped craft in the occurrence of water-related injuries.	Percentage of boating accidents involving foils.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Provide the doctor in charge of the patient with objective data on the most likely lesions and their potential severity.	Distribution of the frequency of different types of injury according to whether or not the foil was used (comparison between the two study groups).	12 months
Analysis of the type and location of lesions observed between the foil and no-foil groups.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient of legal age
Patient not expressing refusal to participate in the study
Patient consulting an emergency room following a boating accident that occurred no more than 7 days previously
Patient able to complete a questionnaire

Exclusion Criteria:

Minor patient
Patients who are illiterate and/or do not understand French
Patient under legal protection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Any person of legal age, meeting the inclusion and non-inclusion criteria, presenting to an emergency department following a boating accident.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Brest		Brest	Finistère	29609	France
Centre Hospitalier Michel Mazéas