Clinical Need for Craniotomy or CraniectomyNCT06201429
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.
A study testing Mechanical Tissue Resuscitation™ (MTR®) in people with Clinical Need for Craniotomy or Craniectomy and Clinical Need for Cranioplasty, run by Renovo Concepts, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Clinical Need for Craniotomy or Craniectomy, Clinical Need for Cranioplasty
- What is being tested?
- Mechanical Tissue Resuscitation™ (MTR®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 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.
- The patient's age is ≥ 22 and ≤ 65 years.
- 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.
- The surgical case is classified as 'clean'.
- Phase 2:
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- All Phase 1 criteria
- Patient has been diagnosed with a mild-to-moderate TBI with a GCS of 9 or above and has two reactive pupils.
- Phase 3:
- All Phase 1 criteria
- Patient has suffered an acute, severe TBI with a GCS of 7-8 and has two reactive pupils.
Who cannot join
- Phase 1:
- Patient has suffered an acute, severe traumatic brain injury, defined as less than 7 days since injury with GCS of less than 13.
- Patient is pregnant or lactating.
- Patient's BMI > 45
- Patient is participating in another clinical investigation.
- Patient's anticipated survival is < 48 hours.
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- Patient is incarcerated at time of hospital admission.
- Patient has a coincidental infection.
- Patient has thrombocytopenia (platelet count < 150,000/µL).
- Patient has an International Normalized Ratio (INR) > 1.5.
- Patient is a known active opioid abuser at the time of surgery.
- Patient is a known active alcohol abuser at the time of surgery.
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University at Buffalo Neurosurgery
Buffalo, New York, 14203
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
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.
Read the detailed description
Mechanical Tissue Resuscitation™ (MTR®) is intended for short-term (up to 7 days) use to externally drain excess fluid volume from the site of surgery in patients who have undergone a surgical procedure (craniotomy/craniectomy) for which a portion of the skull has been removed resulting in exposure of the dura/brain and require drainage of fluid.
This is a single arm early feasibility study. The study will comprise of patients who will receive MTR® therapy to remove fluid from the surgical site in patients that have undergone a craniotomy/craniectomy.
The patient population will include male and female patients ages 22-65 who have undergone a surgical procedure to remove a portion of the skull to expose the dura/brain (craniotomy or 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).
The study will be conducted in subsequent phases, to enroll patients in the following populations:
- Phase 1: patients undergoing elective procedures;
- Phase 2: patients with mild-to-moderate TBI, as defined by a GCS of 9 or above with two reactive pupils; and
- Phase 3: patients with severe TBI, as defined by a GCS of 7 or 8 with two reactive pupils.
Patients will be treated with MTR® for up to seven (7) days, with a follow up evaluation approximately one month post treatment.
- Being tested
- Mechanical Tissue Resuscitation™ (MTR®)
- Keywords
- craniotomy, craniectomy, cranioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Tissue Resuscitation™ (MTR®)Device
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).
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Tissue Resuscitation™ (MTR®) | Experimental | Not described Receives: Device: Mechanical Tissue Resuscitation™ (MTR®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and effectiveness of MTR®
The primary endpoint is to evaluate that MTR® is safe for the removal of fluids in those patients who have undergone a craniotomy/craniectomy/cranioplasty. This endpoint will be assessed by the frequency of device and procedure related adverse events.
Measured: 30 days
Secondary outcomes (6)
MTR® Success
MTR® Success will be defined as:
- Placement: ability to establish and maintain pressure with adequate manifold sizing.
- Maintenance: lack of air leaks and evidence of fluid removal.
- Removal: ability to remove without tissue damage or excessive bleeding.
Measured: 30 days
AEs/SAEs Frequency
Frequency of all adverse events experienced from the time of enrollment through study exit. Events will be categorized as adverse events (AEs) or serious adverse events (SAEs) and measured by site data entry review.
Measured: 30 days
Ability to remove fluid
Ability to remove fluid, measured volume of fluid and rate of removal.
Measured: 7 days
Operator ease survey
Operator survey measured by completion of the following 3 questions on the case report form for:
- ease of manifold placement,
- ease of exit tubing placement,
- ease of establishment of a vacuum seal.
Answered with a five category Likert scale ranging from Extremely Easy to Extremely Difficult.
Measured: 1 day (during day of surgery)
Health care professional (HCP) ease survey
HCP survey regarding ease of system use/maintenance during treatment period.
Answered with a four category Likert scale ranging from Poor to Excellent for each specific category below:
- MTR Manifold (silicone foam) Sheet Placement
- Dome and Tubing Assembly Placement
- Use of Sub-Atmospheric Pressure Pump (SaPP®)
- Vacuum - Site closure
- Fluid Removal
Measured: 1 day (during day of surgery)
Data Integrity
Data integrity measured by the frequency of each type of missing data query seen during the course of the subject's treatment, and frequency of any other protocol deviation recorded during the study.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Need for Craniotomy or CraniectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm early feasibility study. The study will comprise of patients who will receive MTR® therapy to remove fluid from the surgical site in patients that have undergone a craniotomy/craniectomy/cranioplasty.
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renovo Concepts, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201429
- Sponsor's protocol ID
- 2023-01
- Status last verified
- Apr 2026
- First submitted
- 30 Dec 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06201429
- Acronym / sponsor ID
- 2023-01
- Keywords
- craniotomy, craniectomy, cranioplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Renovo Concepts, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mechanical Tissue Resuscitation™ (MTR®) is intended for short-term (up to 7 days) use to externally drain excess fluid volume from the site of surgery in patients who have undergone a surgical procedure (craniotomy/craniectomy) for which a portion of the skull has been removed resulting in exposure of the dura/brain and require drainage of fluid.
This is a single arm early feasibility study. The study will comprise of patients who will receive MTR® therapy to remove fluid from the surgical site in patients that have undergone a craniotomy/craniectomy.
The patient population will include male and female patients ages 22-65 who have undergone a surgical procedure to remove a portion of the skull to expose the dura/brain (craniotomy or 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).
The study will be conducted in subsequent phases, to enroll patients in the following populations:
- Phase 1: patients undergoing elective procedures;
- Phase 2: patients with mild-to-moderate TBI, as defined by a GCS of 9 or above with two reactive pupils; and
- Phase 3: patients with severe TBI, as defined by a GCS of 7 or 8 with two reactive pupils.
Patients will be treated with MTR® for up to seven (7) days, with a follow up evaluation approximately one month post treatment.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm early feasibility study. The study will comprise of patients who will receive MTR® therapy to remove fluid from the surgical site in patients that have undergone a craniotomy/craniectomy/cranioplasty.
| Arm | Type | Receives |
|---|---|---|
| Mechanical Tissue Resuscitation™ (MTR®) | Experimental | Device: Mechanical Tissue Resuscitation™ (MTR®) |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- The patient's age is ≥ 22 and ≤ 65 years.
- 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.
- The surgical case is classified as 'clean'.
- All Phase 1 criteria
Key exclusion criteria (15 listed)
- Patient has suffered an acute, severe traumatic brain injury, defined as less than 7 days since injury with GCS of less than 13.
- Patient is pregnant or lactating.
- Patient's BMI > 45
- Patient is participating in another clinical investigation.
- Patient's anticipated survival is < 48 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Mechanical Tissue Resuscitation™ (MTR®) |
Primary outcome
Safety and effectiveness of MTR®
Time frame: 30 days
The primary endpoint is to evaluate that MTR® is safe for the removal of fluids in those patients who have undergone a craniotomy/craniectomy/cranioplasty. This endpoint will be assessed by the frequency of device and procedure related adverse events.
6 secondary outcomes
MTR® Success
Time frame: 30 days
AEs/SAEs Frequency
Time frame: 30 days
Ability to remove fluid
Time frame: 7 days
Operator ease survey
Time frame: 1 day (during day of surgery)
Health care professional (HCP) ease survey
Time frame: 1 day (during day of surgery)
Data Integrity
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Tissue Resuscitation™ (MTR®) in people with Clinical Need for Craniotomy or Craniectomy and Clinical Need for Cranioplasty, run by Renovo Concepts, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna M Fryzel, MA (1 978-760-6582, anna.fryzel@avaniaclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and effectiveness of MTR® (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.