Oral HemorrhageNCT05171231
Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery
An observational study of Oral Hemorrhage, run by Septodont at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Oral Hemorrhage
- What is being tested?
- HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 125 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 3 Nov 2021to 7 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population is made with the recruitment of participating centers which included at least one patient. The analysis will be carried out on the patients included with evaluable observation sheets . The evaluability of a form will be defined during the development of the analysis plan according to the number of missing data and the nature of missing data. The analysis sets are defined below: * Intented-to-treat (ITT) population: The ITT population consists of all subjects not opposed to the use of their clinical data and implanted by the HEMOCOLLAGENE® medical device. This population will be the primary population analysis for safety and efficacy. * Per Protocol (PP): The PP population includes all the patients implanted by the medical device HEMOCOLLAGENE® without any major deviation from the protocol. Protocol violations will be graded (major / minor) when reviewing data before database lock. This population will be the secondary population analysis.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
France8 sites
Cabinet dentaire
Chassieu, 69680
SCM Chirurgie Dentaire Opéra
Lyon, 69001
Cabinet Medical
Lyon, 69003
HCL-Hospices Civil de Lyon
Lyon, 69007
Cabinet dentaire Grange-Blanche
Lyon, 69008
APHP- Hôpital de la Pitié Salpetrière
Paris, 75004
Cabinet dentaire
Roanne, 42300
Cabinet dentaire
Villefranche-sur-Saône, 69400
Belgium2 sites
Cabinet Dento Médical, cabinet de Nivelles
Baulers, 4 B-1401
Cabinet Dentaire
Brussels, 1180
About this study
Official title: Observational, Multicenter, Prospective Clinical Study, Measuring the Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery
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
- Being tested
- HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD
- Keywords
- Surgical Hemostatic, Oral Surgery
- Medical subject headings
- Oral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MDDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostatic Performance at 5 minutes
Evaluation of the stop of the bleeding 5 minutes after using HEMOCOLLAGENE®.
Measured: 5 minutes after treatment onset
Secondary outcomes (6)
Rate of overall adverse events
overall Safety assessment
Measured: From treatment onset to 30 days
Rate of device related adverse events
Safety assessment relating to the medical device
Measured: From treatment onset to 30 days
Wound Healing
Evaluation of the wound healing using the Landry Score (from "1 - Very Poor" to "5 - Excellent")
Measured: At 30 days
Ease of the use of Hemocollagene by the Dentist
Satisfaction of the dentist on the use and the quality of HEMOCOLLAGENE® :
- Data relating to the hemostatic agent HEMOCOLLAGENE® (number, reference, quality before and during use).
- The technique for using HEMOCOLLAGENE® (cutting before or after application, removal or not for hemostasis, fixing).
- The intraoperative satisfaction of the practitioner.
Measured: At day 0, after using the treatment
Rate of hemostatic time at 10 minutes in case persistant bleeding
Percentage of patients with a bleeding stopped 10 minutes after treatment onset in case of persistant bleeding
Measured: 10 minutes after treatment onset
Rate of persistant bleeding
Percentage of patients with a bleeding not stopped 5 minutes after treatment onset
Measured: 5 minutes after treatment onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start3 Nov 2021
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Septodont
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Symatese, Recherche Clinique en Odontologie (ReCOL), EndoData
- Responsible party
- Sponsor
- Investigators
- Brigitte Grosgogeat, MD, PhD, Study director, CHU de Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171231
- Sponsor's protocol ID
- HEM 2021-07
- Other IDs
- 2021-A01764-37
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guillet, Marie, et al. "Adjuvant Hemostasis in Dental Surgery: Real-Life Practice Data in The Observational, Multi-Center, Prospective, Hemocollagene Clinical Trial." International Journal of Health & Medical Research 3.12 (2024).
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Multicenter, Prospective Clinical Study, Measuring the Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery
- ClinicalTrials.gov ID
- NCT05171231
- Acronym / sponsor ID
- HEM 2021-07
- Conditions
- Oral Hemorrhage
- Keywords
- Surgical Hemostatic, Oral Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- SeptodontIndustry (pharma, biotech, devices)
- Collaborators
- Symatese, Recherche Clinique en Odontologie (ReCOL), EndoData
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is made with the recruitment of participating centers which included at least one patient. The analysis will be carried out on the patients included with evaluable observation sheets . The evaluability of a form will be defined during the development of the analysis plan according to the number of missing data and the nature of missing data. The analysis sets are defined below: * Intented-to-treat (ITT) population: The ITT population consists of all subjects not opposed to the use of their clinical data and implanted by the HEMOCOLLAGENE® medical device. This population will be the primary population analysis for safety and efficacy. * Per Protocol (PP): The PP population includes all the patients implanted by the medical device HEMOCOLLAGENE® without any major deviation from the protocol. Protocol violations will be graded (major / minor) when reviewing data before database lock. This population will be the secondary population analysis.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MDHEMOCOLLAGENE® 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. | Device | – |
Primary outcome
Hemostatic Performance at 5 minutes
Time frame: 5 minutes after treatment onset
Evaluation of the stop of the bleeding 5 minutes after using HEMOCOLLAGENE®.
6 secondary outcomes
Rate of overall adverse events
Time frame: From treatment onset to 30 days
Rate of device related adverse events
Time frame: From treatment onset to 30 days
Wound Healing
Time frame: At 30 days
Ease of the use of Hemocollagene by the Dentist
Time frame: At day 0, after using the treatment
Rate of hemostatic time at 10 minutes in case persistant bleeding
Time frame: 10 minutes after treatment onset
Rate of persistant bleeding
Time frame: 5 minutes after treatment onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publicationGuillet, Marie, et al. "Adjuvant Hemostasis in Dental Surgery: Real-Life Practice Data in The Observational, Multi-Center, Prospective, Hemocollagene Clinical Trial." International Journal of Health & Medical Research 3.12 (2024).
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Grosgogeat, MD, PhD study director
CHU de Lyon, France
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Hemorrhage, run by Septodont at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostatic Performance at 5 minutes (time frame: 5 minutes after treatment onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05171231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.