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Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.

NCT05323448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2026-04-14

No results posted yet for this study

Summary

The aim of this study is to assess the efficacy of the ARISTA AH for restoring hemostasis following a long segment posterior spinal fusion.

Conditions

  • Hemostatics
  • Hemostasis
  • Spinal Deformity
  • Spinal Fusion

Interventions

DEVICE

Control Group

During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent).

DEVICE

ARISTA

During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent). Before surgical wound closure, the corresponding amount of ARISTA-AH will be applied to completely cover the bleeding site : * 5g for 5 to 8 instrumented vertebra * 10g fo 9 or more instrumented vertebra

Sponsors & Collaborators

  • Bard Ltd

    collaborator INDUSTRY

  • Polyclinique Bordeaux Nord Aquitaine

    lead OTHER

Principal Investigators

  • Jean Charles LE HUEC, M.D., PhD · VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-25
Primary Completion
2025-03-09
Completion
2025-07-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05323448 on ClinicalTrials.gov