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

Biom'Up

Status: Terminated

Conditions: Hemostasis

Treatments: Device: HEMOBLAST™ Bellows

Study type: Observational

Funder types: Industry

Identifiers

NCT03873168

ETC 2018-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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