NCT05171231

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: Septodont · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Hemorrhage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-03
• Primary completion: 2022-03-07
• Completion: 2022-03-07
• First posted: 2021-12-28
• Last updated: 2025-04-06

Locations

10 sites across 2 countries: Belgium, France