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

NCT05171231 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2026-05-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Symatese

    collaborator INDUSTRY

  • Recherche Clinique en Odontologie (ReCOL)

    collaborator NETWORK

  • EndoData

    collaborator UNKNOWN

  • Septodont

    lead INDUSTRY

Principal Investigators

  • Brigitte Grosgogeat, MD, PhD · CHU de Lyon, France

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2022-03-07
Completion
2022-03-07

Countries

  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05171231 on ClinicalTrials.gov