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

NCT03873168 | Terminated FDA Device

• 1 other identifier: ETC 2018-001
• Study Type: observational
• Target: 64
• Locations: 3 countries
• Sites: 9

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.

Conditions

Hemostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Re-bleeding at Target Bleeding Site

  Intraoperative, prior to surgical closure of the subject

• Re-operation due to bleeding

  Post-operatively, expected within 1-30 days of the surgical procedure

Interventions

HEMOBLAST™ Bellows DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Biom'Up France SAS: lead

Study Sites (9)

Uniklinikum

Salzburg, Austria

Location

Centre Hospitalier Universitaire d'Angers

Angers, France

Location

CHU Grenoble

Grenoble, France

Location

Hopital Saint-Joseph

Paris, 75014, France

Location

Clinique Rive Gauche

Toulouse, 31300, France

Location

Universitatsklinikum Bonn

Bonn, 53127, Germany

Location

Kliniken der Stadt Koln, Krankenhaus Merheim

Cologne, 51067, Germany

Location

Agaplesion Markus krankenhaus

Frankfurt, 60487, Germany

Location

St Franzikus-Hospital

Münster, 48145, Germany

Location

Study Officials

• Tim Vilz, MD

  Unversity Hospital Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: May 9, 2019
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

DE (4); AU (1); FR (4)