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COMPLETED
NCT05171231

Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery

Sponsor: Septodont

View on ClinicalTrials.gov

Summary

The aim of this study is to collect performance and safety data relating to the use and the follow-up of the HEMOCOLLAGENE® medical device in routine clinical practice from various hospitals and medical centers in oral dental surgery. Patients will The data collected from the Post-Market Clinical Follow-up study will be used to support the regulatory requirements of post-market monitoring (risk management, residual risks, instructions for use...) and to increase the manufacturer's clinical data. Patients will be followed for 1 month. Adverse events (safety) and device performance will be collected by the dentist during the routine follow-up visits.

Official title: Observational, Multicenter, Prospective Clinical Study, Measuring the Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery

Key Details

Gender

All

Age Range

10 Years - Any

Study Type

OBSERVATIONAL

Enrollment

125

Start Date

2021-11-03

Completion Date

2022-03-07

Last Updated

2026-05-06

Healthy Volunteers

No

Conditions

Interventions

DEVICE

HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD

HEMOCOLLAGENE® is an absorbable, sterile and hemostatic sponge, composed of type I undenatured, native and lyophilized bovine collagen (0.027 g per sponge). HEMOCOLLAGENE® will be inserted into oral sites (mainly the alveoli dental) after post-extraction or post-invasive dental surgical procedure, in case of bleeding not controled by usual hemostatic method. HEMOCOLLAGENE® will be let in place and will undergo a complete and natural absorption after several weeks.

Locations (10)

Cabinet Dento Médical, cabinet de Nivelles

Baulers, Belgium

Cabinet Dentaire

Brussels, Belgium

Cabinet dentaire

Chassieu, France

SCM Chirurgie Dentaire Opéra

Lyon, France

Cabinet Medical

Lyon, France

HCL-Hospices Civil de Lyon

Lyon, France

Cabinet dentaire Grange-Blanche

Lyon, France

APHP- Hôpital de la Pitié Salpetrière

Paris, France

Cabinet dentaire

Roanne, France

Cabinet dentaire

Villefranche-sur-Saône, France