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