Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery (NOBLE-Laparo)

Post-Market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Laparoscopic Abdominal, Gynecological and Urological Surgery

A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery.

Study Overview

• Status: Completed
• 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 laparoscopic abdominal, gynecological, and urological surgery. Up to 100 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): 102

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria
    • University Hospital Salzburg
• France
  • Clichy, France
    • Hopital Beaujon
  • Grenoble, France
    • CHU Grenoble
  • Paris, France, 75674
    • Hôpital Saint Jospeh
• Germany
  • Bonn, Germany
    • University Hospital Bonn
  • Frankfurt am main, Germany, 60487
    • Agaplesion Markus Krankenhaus
  • Hamburg, Germany
    • Asklepios Klinik Barmbek
  • Köln, Germany, 51109
    • Kliniken der Stadt Koln, Krankenhaus Merheim

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 laparoscopic abdominal, gynecological, or urological 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 laparoscopic abdominal, gynecological, or urological 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 HEMOBLAST™ Bellows and the HEMOBLAST™ Bellows Laparoscopic Applicator 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, University Hospital, Bonn

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Actual): August 26, 2020
• Study Completion (Actual): August 26, 2020

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): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ETC 2018-002

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