Clinical trial NCT03873168: Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries
Official title: Post-Market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Open Gynecological, Urological, ENT, Head and Neck, and Vascular Surgeries
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hemostasis
Lead sponsor: Biom'Up France SAS
Sponsor class: INDUSTRY
First posted: 2019-03-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing open gynecological, urological, ENT and head and neck, and vascular procedures that meet all of the inclusion criteria and none of the exclusion criteria.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Achievement of Hemostasis
timeFrame: Intraoperatively, expected within 3-10 minutes of application
Secondary outcomes:
measure: Re-bleeding at Target Bleeding Site
timeFrame: Intraoperative, prior to surgical closure of the subject
measure: Re-operation due to bleeding
timeFrame: Post-operatively, expected within 1-30 days of the surgical procedure
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Uniklinikum
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Grenoble
country: France
facility: CHU Grenoble
city: Paris
country: France
facility: Hopital Saint-Joseph
city: Toulouse
country: France
facility: Clinique Rive Gauche
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Frankfurt
country: Germany
facility: Agaplesion Markus krankenhaus
city: Köln
country: Germany
facility: Kliniken der Stadt Koln, Krankenhaus Merheim
city: Münster
country: Germany
facility: St Franzikus-Hospital
Study officials:
affiliation: Unversity Hospital Bonn
name: Tim Vilz, MD
role: PRINCIPAL_INVESTIGATOR
References: