CompletedNot Applicable

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

Belgium, France125 participantsStarted 2021-11-03

Plain-language 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.

Who can participate

Age range10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient requiring oral surgery * Patient with a bleeding requiring the use of an adjuvant hemostatic * Patient implanted with HEMOCOLLAGENE® in dental surgery. * Patient who signed his informed consent form Exclusion Criteria: * Inform Consent not signed * Patients with acute oral infection. * Patients with an unstable hemodynamic state (acute and/or chronic cardiovascular pathology, low arterial pressure, cardiac rhythm problem) * Pregnant and / or breastfeeding patients. * Patient with hypersensitivity or allergy to bovine collagen

What they're measuring

Hemostatic Performance at 5 minutes

Timeframe: 5 minutes after treatment onset

Trial details

NCT IDNCT05171231

SponsorSeptodont

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-03-07

View on ClinicalTrials.gov More Oral Hemorrhage trials