Clinical trial NCT06037265: PR-0164 First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System
Official title: First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System to Evaluate Safety and Performance
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease stage3
Chronic Kidney Disease stage4
Chronic Kidney Disease Stage 5
Poor Vascular Access
Lead sponsor: PAVmed Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The PortIO is intended to provide non-emergent vascular access in chronic kidney disease (CKD) patients where preservation of venous anatomy is desired and iatrogenic damage to the veins should be avoided and/or patients with poor/difficult vascular access. The PortIO device may be inserted into the proximal or distal tibia or the proximal humerus in adults, and provides up to 60 days of intraosseous vascular access for delivery of fluids and medications.

Detailed description: This is a prospective, open label, single arm, non-randomized, multicentric first in human clinical trial of the PortIO device for intraosseous infusion of fluids and/or medications for up to 60 days in subjects that meet the inclusion criteria. Both hospitalized patients as well as outpatients can be screened and, if appropriate, can be consented and enrolled into the study. They will have the PortIO device implanted by a qualified physician and then undergo prescribed infusions as needed and determined by the treating physician over either a 7-day or a 60-day period. The device will then be removed after the 7 days or 60 days of use and the subject followed up at 30 days after explant.

Eligibility criteria: Inclusion Criteria:

* Subjects must meet the following criteria are eligible for participation in the study:

  1. Subject is \> 22 years old
  2. Subject has grade 3 or higher CKD and is receiving or may receive renal replacement therapy with hemodialysis OR has poor/difficult vascular access.
  3. Subject does NOT need urgent or emergent vascular access;
  4. Subject, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
  5. Subject is willing and able to complete follow-up requirement

Exclusion Criteria:

* Subjects must be EXCLUDED from participation in this study if ANY of the following criteria are met:

  1. Fracture (within 6 months), bone tumor, or structural bone abnormality (such as osteogenesis imperfect, avascular necrosis, and severe osteoporosis) of the target bone
  2. Excessive overlying soft tissue, nerves, arteries, tendons or absence of anatomic landmarks at the target site
  3. Previous orthopedic procedure at or near the insertion site (e.g. artificial joint, rigid fixation hardware)
  4. IO access or attempted IO access in the target bone within 7 days
  5. Known or suspected allergy to any device component or materials contained in the device
  6. Local tissue factors preventing proper device stabilization and / or access including local infection, fragile tissue and absence of adequate or excessive overlying soft tissue.
  7. Subject with known unstable cardiac disease (recent MI within 30 days, cardiac surgery within 6 months, unstable angina, severe aortic stenosis/regurgitation, severe congestive heart failure, severe mitral stenosis/regurgitation), uncontrolled diabetes (blood glucose \>240 mg/dl) or subjects on immunosuppressive medications (e.g. organ transplant patients)
  8. Subjects who are anticipated to receive infusion of blood or blood products, chemotherapeutic agents, hypertonic solutions, caustic agents or any agents known to harm bone marrow or cause bone marrow suppression such as azathioprine, procainamide, sulfasalazine via the test device.
  9. Insertion into the humerus on the same side as a previous mastectomy
  10. Known allergy to contrast media or local anesthetics (e.g. lidocaine, bupivacaine)
  11. Subjects with known bleeding disorders including thrombocytopenia, thrombasthenia, hemophilia or Von Willebrand's disease.
  12. Subjects with a history of hypercoagulable disorders such as protein S or C deficiency, Factor 5 Leiden resistance, Antithrombin III deficiency, Antiphospholipid antibody syndrome, Heparin Induced Thrombocytopenia etc.
  13. Subjects who are anticipated to need power injections via the test device for CT scan or angiography
  14. Subject has other medical, social or psychological problem that in the opinion of the investigator precludes them from fully participating
  15. Women who are pregnant, women who are attempting to become pregnant, as well as women who are breast feeding.

Primary outcomes:
measure: Primary Performance
timeFrame: Entire duration of Study an average of 2 years
measure: Primary Safety
timeFrame: Entire duration of Study and average of 2 years
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: Entire duration of Study an average of 2 years
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Cediul
state: Atlantico
city: Barranquilla
country: Colombia
facility: Sabbag Radiologos
state: Atlantico
city: Bogotá
country: Colombia
facility: Cirulaser Andes
state: Bogota
city: Cali
country: Colombia
facility: Centro Medico Imbanaco
state: Valle De Cauca
Study officials:
affiliation: Lucid Diagnostics
name: Gisella Lopez
role: STUDY_DIRECTOR
References: