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

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

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.

Study Overview

• Status: Terminated
• Conditions: Hemostasis
• Intervention / Treatment: Device: HEMOBLAST™ Bellows

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.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria
    • Uniklinikum
• France
  • Angers, France
    • Centre Hospitalier Universitaire d'Angers
  • Grenoble, France
    • CHU Grenoble
  • Paris, France, 75014
    • Hôpital Saint-Joseph
  • Toulouse, France, 31300
    • Clinique Rive Gauche
• Germany
  • Bonn, Germany, 53127
    • Universitatsklinikum Bonn
  • Frankfurt, Germany, 60487
    • Agaplesion Markus Krankenhaus
  • Köln, Germany, 51067
    • Kliniken der Stadt Koln, Krankenhaus Merheim
  • Münster, Germany, 48145
    • St Franzikus-Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Biom'Up France SAS
• Investigators: Principal Investigator: Tim Vilz, MD, Unversity Hospital Bonn

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 9, 2019
• Primary Completion (ACTUAL): July 27, 2021
• Study Completion (ACTUAL): July 27, 2021

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (ACTUAL): March 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ETC 2018-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No