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.

NCT ID: NCT06201429

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2024-06-15

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.

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) in which the dura is intact or has been closed (repaired), and who, as an integral part of their care would require placement of a Jackson Pratt drain.

Patients will be treated with MTR™ for up to seven (7) days, with a follow up evaluation approximately one month post treatment.

Patients who have suffered a traumatic brain injury (TBI) and require such a surgical procedure are not to be included in the patient population for this early feasibility study.

Conditions

Clinical Need for Craniotomy or Craniectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Mechanical Tissue Resuscitation (MTR™)

Group Type: EXPERIMENTAL

Mechanical Tissue Resuscitation (MTR™)

Intervention Type: DEVICE

Mechanical Tissue Resuscitation (MTR™) 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.

Interventions

Mechanical Tissue Resuscitation (MTR™)

Mechanical Tissue Resuscitation (MTR™) 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient is willing and able to provide written informed consent.

2. The patient's age is ≥ 22 and ≤ 65 years.

3. The patient has a clinical need for a craniotomy/craniectomy and for which, as an integral part of their care, a Jackson Pratt (JP) drain would be placed at the surgical site.

4. The surgical case is classified as 'clean'.

Exclusion Criteria

1. Patient has suffered a traumatic brain injury.

2. Patient is pregnant or lactating.

3. Patient's BMI = (Weight (lb) x 703)/(〖Height〗^2 (inches)) > 45; BMI may also be calculated at http://nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm

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 an active opioid abuser.

11. Patient is an active alcohol abuser.

12. There is active bleeding at the site of surgery.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renovo Concepts, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Anna M Fryzel, MA

Role: CONTACT

anna.fryzel@avaniaclinical.com

1 508 351 8632

Other Identifiers

2023-01

Identifier Type: -

Identifier Source: org_study_id