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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01764-37 | Registry Identifier | French ID-RCB |
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| Name | Class |
|---|---|
| Symatese | INDUSTRY |
| Recherche Clinique en Odontologie (ReCOL) | NETWORK |
| EndoData | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostatic Performance at 5 minutes | Evaluation of the stop of the bleeding 5 minutes after using HEMOCOLLAGENE®. | 5 minutes after treatment onset |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of overall adverse events | overall Safety assessment | From treatment onset to 30 days |
| Rate of device related adverse events | Safety assessment relating to the medical device |
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Inclusion Criteria:
Exclusion Criteria:
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Grosgogeat, MD, PhD | CHU de Lyon, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet Dento Médical, cabinet de Nivelles | Baulers | 4 B-1401 | Belgium | |||
| Cabinet Dentaire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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). |
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| From treatment onset to 30 days |
| Wound Healing | Evaluation of the wound healing using the Landry Score (from "1 - Very Poor" to "5 - Excellent") | At 30 days |
| Ease of the use of Hemocollagene by the Dentist | Satisfaction of the dentist on the use and the quality of HEMOCOLLAGENE® :
| 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 | 10 minutes after treatment onset |
| Rate of persistant bleeding | Percentage of patients with a bleeding not stopped 5 minutes after treatment onset | 5 minutes after treatment onset |
| Brussels |
| 1180 |
| Belgium |
| Cabinet dentaire | Chassieu | 69680 | France |
| SCM Chirurgie Dentaire Opéra | Lyon | 69001 | France |
| Cabinet Medical | Lyon | 69003 | France |
| HCL-Hospices Civil de Lyon | Lyon | 69007 | France |
| Cabinet dentaire Grange-Blanche | Lyon | 69008 | France |
| APHP- Hôpital de la Pitié Salpetrière | Paris | 75004 | France |
| Cabinet dentaire | Roanne | 42300 | France |
| Cabinet dentaire | Villefranche-sur-Saône | 69400 | France |
| ID | Term |
|---|---|
| D006472 | Oral Hemorrhage |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009912 | Oral Manifestations |
| D012816 | Signs and Symptoms |
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