BleedingNCT05177887
Traumacel PULVIS and Traumacel ENDO Applicator in the Post-market Surveillance Phase
A study testing Traumacel PULVIS, Traumacel ENDO Applicator in people with Bleeding and Surgical Wound, run by Bioster, a.s. at 1 site in Czechia.
Trial summary
Traumacel PULVIS is a sterile absorbable haemostatic plant polysaccharide powder made of the oxidized cellulose. Traumacel PULVIS is designed to stop capillary bleeding as well as to prevent bleeding in the early post-operative stage, for example to stop capillary bleeding from resection areas of parenchymatous… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Bleeding, Surgical Wound
- What is being tested?
- Traumacel PULVIS, Traumacel ENDO Applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2022to 1 Feb 2023
- Phase
- Interventional
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age of 18.
- Surgical intervention.
- Negative pregnancy test of women in fertile age.
- Diffuse soft tissue, vascular or parenchymal haemorrhage after conventional surgical haemostatic methods have not worked or are impractical (e.g. ligation, suture, compression, cauterisation).
- Informed consent.
Who cannot join
- Hypersensitivity or a known reaction to oxidized cellulose.
- Age under 18
- A severe clinical condition of the patient (e.g. associated illness, mental disorder) which, according to the investigator, could adversely affect patient safety and/or compliance with the procedures used in the study.
- The patient has participated in another clinical study involving a haemostatic product within 30 days prior to enrolment, or another such clinical study is planned during the subject's participation in the study.
- Pregnancy or lactation.
- If during the procedure itself, there was no need to use the test agent
- Application of any other topical haemostatic product prior to application of the test agent to the same site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric, Prospective Clinical Study of Traumacel PULVIS Haemostatic Powder Application With or Without the Use of Traumacel ENDO Applicator in the Post-market Surveillance Phase
Traumacel PULVIS is a sterile absorbable haemostatic plant polysaccharide powder made of the oxidized cellulose. Traumacel PULVIS is designed to stop capillary bleeding as well as to prevent bleeding in the early post-operative stage, for example to stop capillary bleeding from resection areas of parenchymatous organs, muscles, to stop bleeding after endoscopy, mainly rectoscopic, procedures. The broadness of application allows for use in procedures performed in the standard way as well as endoscopically.
Traumacel ENDO Applicator is a single use, flexible, manual apparatus designed to deliver the absorbable haemostatic powder Traumacel PULVIS.
Read more
The main objective of this clinical study is to confirm the safety and efficacy of the medical device Traumacel PULVIS and Traumacel ENDO Applicator when used in accordance with their intended purpose.
The partial objectives are: to identify potential incompatibilities of Traumacel ENDO Applicator with other surgical instruments, in particular with different types of trocar cannulas; for both devices (Traumacel ENDO Applicator and Traumacel PULVIS) the identification and analysis of potential emerging risks; confirmation of the acceptability of the benefit-risk ratio; identification of any systematic misuse of the device or off-label use of the device in order to verify the correctness of its intended purpose.
- Conditions
- Bleeding, Surgical Wound
- Being tested
- Traumacel PULVIS, Traumacel ENDO Applicator
- Keywords
- Oxidized cellulose, Haemostatic agent
- Medical subject headings
- Hemorrhage, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traumacel PULVIS, Traumacel ENDO ApplicatorDevice
Also called Traumastem POWDER, Traumastem ENDO Applicator, EMOXICEL EMIPOL, Traumastem P
Haemostatic plant polysaccharide powder made of the oxidized cellulose with flexible applicator (38 cm).
| Study group | Role | What they receive |
|---|---|---|
| Traumacel PULVIS | Experimental | Traumacel PULVIS will be poured into the bleeding area directly or using an applicator Traumacel ENDO Applicator. Receives: Device: Traumacel PULVIS, Traumacel ENDO Applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required to achieve haemostasis
Measured: 10 minutes
Number of subjects in whom haemostasis was achieved within 3 minutes after administration
Measured: 3 minutes
Number of subjects who required a surgical revision within 12 hours after the procedure for recurrent bleeding
Measured: 12 hours
Secondary outcomes (2)
Degree of bleeding from target bleeding site
Measured: 10 minutes
Occurrence of adverse events
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Feb 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioster, a.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177887
- Sponsor's protocol ID
- PMCF-29-11-20
- Status last verified
- Jul 2023
- First submitted
- 1 Dec 2021
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Prospective Clinical Study of Traumacel PULVIS Haemostatic Powder Application With or Without the Use of Traumacel ENDO Applicator in the Post-market Surveillance Phase
- ClinicalTrials.gov ID
- NCT05177887
- Acronym / sponsor ID
- PMCF-29-11-20
- Conditions
- Bleeding, Surgical Wound
- Keywords
- Oxidized cellulose, Haemostatic agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bioster, a.s.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 5 Jan 2022 (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.
Traumacel PULVIS is a sterile absorbable haemostatic plant polysaccharide powder made of the oxidized cellulose. Traumacel PULVIS is designed to stop capillary bleeding as well as to prevent bleeding in the early post-operative stage, for example to stop capillary bleeding from resection areas of parenchymatous organs, muscles, to stop bleeding after endoscopy, mainly rectoscopic, procedures. The broadness of application allows for use in procedures performed in the standard way as well as endoscopically.
Traumacel ENDO Applicator is a single use, flexible, manual apparatus designed to deliver the absorbable haemostatic powder Traumacel PULVIS.
The main objective of this clinical study is to confirm the safety and efficacy of the medical device Traumacel PULVIS and Traumacel ENDO Applicator when used in accordance with their intended purpose.
The partial objectives are: to identify potential incompatibilities of Traumacel ENDO Applicator with other surgical instruments, in particular with different types of trocar cannulas; for both devices (Traumacel ENDO Applicator and Traumacel PULVIS) the identification and analysis of potential emerging risks; confirmation of the acceptability of the benefit-risk ratio; identification of any systematic misuse of the device or off-label use of the device in order to verify the correctness of its intended purpose.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumacel PULVIS | Experimental | Device: Traumacel PULVIS, Traumacel ENDO ApplicatorTraumacel PULVIS will be poured into the bleeding area directly or using an applicator Traumacel ENDO Applicator. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimum age of 18.
- Surgical intervention.
- Negative pregnancy test of women in fertile age.
- Diffuse soft tissue, vascular or parenchymal haemorrhage after conventional surgical haemostatic methods have not worked or are impractical (e.g. ligation, suture, compression, cauterisation).
- Informed consent.
Key exclusion criteria (7 listed)
- Hypersensitivity or a known reaction to oxidized cellulose.
- Age under 18
- A severe clinical condition of the patient (e.g. associated illness, mental disorder) which, according to the investigator, could adversely affect patient safety and/or compliance with the procedures used in the study.
- The patient has participated in another clinical study involving a haemostatic product within 30 days prior to enrolment, or another such clinical study is planned during the subject's participation in the study.
- Pregnancy or lactation.
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 |
|---|---|---|
| Traumacel PULVIS, Traumacel ENDO ApplicatorAlso: Traumastem POWDER, Traumastem ENDO Applicator, EMOXICEL EMIPOL, Traumastem PHaemostatic plant polysaccharide powder made of the oxidized cellulose with flexible applicator (38 cm). | Device | Traumacel PULVIS |
Primary outcome
Time required to achieve haemostasis
Time frame: 10 minutes
Number of subjects in whom haemostasis was achieved within 3 minutes after administration
Time frame: 3 minutes
Number of subjects who required a surgical revision within 12 hours after the procedure for recurrent bleeding
Time frame: 12 hours
2 secondary outcomes
Degree of bleeding from target bleeding site
Time frame: 10 minutes
Occurrence of adverse events
Time frame: 1 month
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 28 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traumacel PULVIS, Traumacel ENDO Applicator in people with Bleeding and Surgical Wound, run by Bioster, a.s. at 1 site in Czechia.
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 5 inclusion and 7 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 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
Time required to achieve haemostasis (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2023.