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Clinical Trials/NL-OMON49958
NL-OMON49958
Completed
Not Applicable

Study of the change in Intra-Abdominal Pressure during spine surgery in the prone position - SIAP - Spine Intra-Abdominal Pressure study

Ergotrics nv0 sites40 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Ergotrics nv
Enrollment
40
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
March 30, 2022
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Sponsor
Ergotrics nv

Eligibility Criteria

Inclusion Criteria

  • •Age 18\-80 at time of surgery
  • •Subject planned to undergo spine surgery in prone position
  • •Subject planned to have transurethral bladder catheter during surgery
  • •Body weight \* 120kg

Exclusion Criteria

  • •Abdominal or urethral surgery during past 12 months.
  • •Contraindication to use of transurethral bladder catheter
  • •History of recent (\<3 months) urinary tract or bladder infection.
  • •Known allergy to IPS material
  • •Current systemic infection or local infection
  • •Current known pregnancy
  • •Subject is participating in an investigational study
  • •Coagulation Issues/disorders

Outcomes

Primary Outcomes

Not specified

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