Recruiting

Mechanical Tissue Resuscitation

Sponsor:

Renovo Concepts, Inc.

Code:

NCT06201429

Conditions

Clinical Need for Craniotomy or Craniectomy

Clinical Need for Cranioplasty

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

Mechanical Tissue Resuscitation™ (MTR®)

Study Details

Brief summary:

A multi-center, early feasibility study of using the Mechanical Tissue Resuscitation™ (MTR®) therapy system for removal of excess fluid in subjects who have had a portion of their skull removed to expose the dura/brain and require drainage for fluid removal.

Conditions

Clinical Need for Craniotomy or Craniectomy

Clinical Need for Cranioplasty

Study ID

NCT06201429

Start date

Nov 1, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

Phase 1:

1. Patient is willing and able to provide written informed consent or has an appointed legally authorized representative (LAR) who can provide consent on the patient's behalf.
2. The patient's age is ≥ 22 and ≤ 65 years.
3. The patient has a clinical need for a craniotomy, craniectomy, or cranioplasty and for which, as an integral part of their care, a Jackson Pratt (JP) drain or equivalent would be placed at the surgical site.
4. The surgical case is classified as 'clean'.

Phase 2:

1. All Phase 1 criteria
2. Patient has been diagnosed with a mild-to-moderate TBI with a GCS of 9 or above and has two reactive pupils.

Phase 3:

1. All Phase 1 criteria
2. Patient has suffered an acute, severe TBI with a GCS of 7-8 and has two reactive pupils.

Exclusion Criteria:

Phase 1:

1. Patient has suffered an acute, severe traumatic brain injury, defined as less than 7 days since injury with GCS of less than 13.
2. Patient is pregnant or lactating.
3. Patient's BMI > 45
4. Patient is participating in another clinical investigation.
5. Patient's anticipated survival is < 48 hours.
6. Patient is incarcerated at time of hospital admission.
7. Patient has a coincidental infection.
8. Patient has thrombocytopenia (platelet count < 150,000/µL).
9. Patient has an International Normalized Ratio (INR) > 1.5.
10. Patient is a known active opioid abuser at the time of surgery.
11. Patient is a known active alcohol abuser at the time of surgery.
12. Active bleeding at the site of surgery prior to placement of the device.

Phases 2 and 3:

1\. Exclusion criteria 2-12 from Phase 1

Study Design

Enrollment

11 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Mechanical Tissue Resuscitation™ (MTR®)

Interventions

Mechanical Tissue Resuscitation™ (MTR®)

Mechanical Tissue Resuscitation™ (MTR®) to drain excess fluid volume from the site of surgery in patients who have undergone a surgical procedure (craniotomy/craniectomy), or a procedure in which a portion of the skull has been repaired or replaced (cranioplasty), and who, as an integral part of their care would require placement of a Jackson Pratt drain (or equivalent).

Primary outcome measure

  • Safety and effectiveness of MTR® [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

University at Buffalo Neurosurgery

Recruiting

Buffalo, New York, United States, 14203

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

More Information

Sponsor

Renovo Concepts, Inc.

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • craniotomy
  • craniectomy
  • cranioplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Renovo Concepts, Inc. on 2026-05-04.