Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery

B

Biom'Up

Status

Withdrawn

Conditions

Hemostasis

Treatments

Device: HEMOBLAST™ Bellows

Study type

Observational

Funder types

Industry

Identifiers

NCT04471350
ETC 2018-004

Details and patient eligibility

About

Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery

Full description

Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery. Up to 80 subjects will be enrolled at up to 6 sites.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Pre-operative Inclusion Criteria:

  • Patient is undergoing a non-emergent spine 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 per 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 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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