NCT07118020

Brief Summary

This is a post market prospective, multi-center study of up to 75 participants at approximately 8 clinical study sites. The objective of the study is to evaluate safety by assessing incidence of device and/or procedure related adverse events.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

August 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 21, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

2.2 years

First QC Date

August 5, 2025

Last Update Submit

November 20, 2025

Conditions

Craniotomy

Outcome Measures

Primary Outcomes (1)

  • Device and/or Procedure Related Adverse Events

    12 months

Secondary Outcomes (2)

  • Rate of cerebrospinal fluid leakage

    12 months

  • Incidence of re-operation

    12 months

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants in this study will be candidates for craniotomy due to tumor, aneurysm, trauma or other medical conditions recruited from the participating investigator's population

You may qualify if:

  • Males and females of any age undergoing craniotomy
  • Able to return for scheduled study visits
  • Informed consent is able to be obtained

You may not qualify if:

  • Life expectancy \< 12 months
  • Local cerebral infection
  • Previous surgery at same anatomical site
  • Currently enrolled in another study that would affect validity of study
  • Known hypersensitivity to bovine collagen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitatsklinik fur Neurochirurgie der PMU

Salzburg, Austria

Location

Hospital Universitari Vali d'Hebron

Barcelona, Spain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 12, 2025

Study Start

September 21, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 25, 2025

Record last verified: 2025-11

Locations

ES(1)AU(1)