Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries

Hemostasis Clinical Trial

— NOBLE-Open  

Official title:

Post-Market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Open Gynecological, Urological, ENT, Head and Neck, and Vascular Surgeries

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03873168
• Other study ID #: ETC 2018-001
• Status: Terminated
• Start date: May 9, 2019
• Est. completion date: July 27, 2021

Study information

• Verified date: August 2021
• Source: Biom'Up France SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.

Description:

A prospective, multi-center, multi-national single arm study conducted in Austria, France, and Germany to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT, head and neck, and vascular surgery. Up to 120 subjects will be enrolled at up to 10 sites, with a minimum of 8 subjects enrolled in each surgical specialty.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: July 27, 2021
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Pre-operative Inclusion Criteria:

• Patient is undergoing a non-emergent open gynecological, urological, ENT, head and neck, or vascular surgery

• Patient is willing and able to give prior written informed consent for investigation participation;

• Patient is 18 years of age or older.

Intra-operative Inclusion Criteria

• Patient has one or more target bleeding sites (TBS) for which control of bleeding by conventional procedures is ineffective or impractical.

• The TBS(s) has been treated with HEMOBLASTTM Bellows as per their instructions for use.

Exclusion Criteria:

• Patient is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;

• Patient has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;

• Patient has religious or other objections to porcine, bovine, or human components;

• Patient has any significant coagulation disorder;

• Patient has any other contraindications, warnings, precautions of the Approved Instruction For Use of HEMOBLAST™ Bellows preventing his/ her inclusion

• Patient is not appropriate for inclusion in the clinical trial, per the medical opinion of the Investigator

Related Conditions & MeSH terms

• Hemostasis

Intervention

Device:
• HEMOBLAST™ Bellows
Surgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in gynecological, urological, vascular, ENT and head and neck surgeries.

Locations

Country	Name	City	State
Austria	Uniklinikum	Salzburg
France	Centre Hospitalier Universitaire d'Angers	Angers
France	CHU Grenoble	Grenoble
France	Hopital Saint-Joseph	Paris
France	Clinique Rive Gauche	Toulouse
Germany	Universitatsklinikum Bonn	Bonn
Germany	Agaplesion Markus krankenhaus	Frankfurt
Germany	Kliniken der Stadt Koln, Krankenhaus Merheim	Köln
Germany	St Franzikus-Hospital	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Biom'Up France SAS

Countries where clinical trial is conducted

Austria,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of Hemostasis	The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.	Intraoperatively, expected within 3-10 minutes of application
Secondary	Re-bleeding at Target Bleeding Site	The rate of target bleeding site re-bleeding after hemostasis has been achieved with HEMOBLAST™ Bellows	Intraoperative, prior to surgical closure of the subject
Secondary	Re-operation due to bleeding	The rate of re-operation due to post-operative bleeding/hemorrhage after treatment with HEMOBLAST™ Bellows	Post-operatively, expected within 1-30 days of the surgical procedure