Traumacel PULVIS and Traumacel ENDO Applicator in the Post-market Surveillance Phase

NCT ID: NCT05177887

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-02-01

Brief 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 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.

Conditions

Bleeding; Surgical Wound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Traumacel PULVIS

Traumacel PULVIS will be poured into the bleeding area directly or using an applicator Traumacel ENDO Applicator.

Group Type: EXPERIMENTAL

Traumacel PULVIS, Traumacel ENDO Applicator

Intervention Type: DEVICE

Haemostatic plant polysaccharide powder made of the oxidized cellulose with flexible applicator (38 cm).

Interventions

Traumacel PULVIS, Traumacel ENDO Applicator

Haemostatic plant polysaccharide powder made of the oxidized cellulose with flexible applicator (38 cm).

Intervention Type: DEVICE

Other Intervention Names

Traumastem POWDER, Traumastem ENDO Applicator; EMOXICEL EMIPOL; Traumastem P

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioster, a.s.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Hradec Králové

Hradec Králové, , Czechia

Countries

Czechia

Other Identifiers

PMCF-29-11-20

Identifier Type: -

Identifier Source: org_study_id