Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03873168
Other study ID # ETC 2018-001
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05335525 - Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
Completed NCT02583854 - Comparison Study of Compression Devices Used in Transradial Coronary Angiography N/A
Recruiting NCT05977946 - Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects N/A
Completed NCT01388491 - A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women Phase 2
Recruiting NCT04728087 - ACCEL Absorbable Hemostat N/A
Recruiting NCT05323448 - Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion. N/A
Recruiting NCT06078735 - Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study N/A
Completed NCT03907111 - Compare the Hemostatic Effectiveness of Chitosan Gauze With Traditional Gauze on Open Wound on 10 Participants. N/A
Recruiting NCT05875272 - Interchangeability of Arterial Coagulation and Venous Coagulation, in the Context of Cardiac Surgeries Under Cardiopulmonary Bypass, Using the DMDiv Hemochron Signature Elite
Completed NCT04593667 - Randomized Study of Accelerated Radial Arterial Hemostasis N/A
Completed NCT01252186 - A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women Phase 2
Terminated NCT00802633 - Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device? N/A
Completed NCT02034799 - Phase IV Bioseal Study in Brain Tumor Surgery Phase 4
Recruiting NCT04377490 - Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy
Completed NCT00449410 - Silent Cerebrovascular Lesion and Cognitive Decline Prevention by Cholesterol Lowering in Elderly AF Patients Phase 4
Completed NCT03873181 - Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery
Completed NCT04660721 - A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery Phase 1/Phase 2
Recruiting NCT05653843 - MANTIS Endoscopic Clipping Study
Completed NCT00658723 - The Fibrin Patch Soft Tissue Study Phase 2
Recruiting NCT03323359 - Efficacy and Tolerability of Hemopatch After Hepatic Resection N/A