A Prospective Clinical Study Evaluating the Harvesting of Micografts

NCT05076578 | Completed FDA Device

• 1 other identifier: ARTIST-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

ART (Autologous Regeneration of Tissue) is a revolutionary technology for harvesting skin without the drawbacks of conventional grafting. This innovative system allows the clinician to collect hundreds of microcolumns of full-thickness skin tissue and apply them directly to the wound site. It can all be done in an outpatient setting with minimized donor site concerns.

Conditions

Chronic Wound

Outcome Measures

Primary Outcomes (3)

• To evaluate wound closure

  Evaluating Wound Closure with Surface area through measurments

  4 weeks

• Group A (Healthy Volunteers): The number of successful full thickness micrograft harvests from calf, thigh, and lower back as a percentage of the maximal possible grafts.

  Group A (Healthy Volunteers): The number of successful full thickness micrograft harvests from calf, thigh, and lower back as a percentage of the maximal possible grafts.

  4 weeks

• Group B (Chronic Wound patients): The number of wounds achieving a percentage area reduction (PAR) of 40% or greater in 4 weeks.

  Group B (Chronic Wound patients): The number of wounds achieving a percentage area reduction (PAR) of 40% or greater in 4 weeks.

  4 weeks

Secondary Outcomes (5)

• Proportion of patients that achieve complete wound closure

  4 weeks

• Time to initial wound closure within 4 weeks (Kaplan-Meier approach).

  4 weeks

• Difference in pain between baseline

  4 weeks

• Number of Treatments used per patient.

  4 weeks

• • Incidence of adverse events (calculated as total and mean number per patient).

  4 weeks

Other Outcomes (8)

• Ease of use for the Autologous Regeneration of Tissue (ART) system using System Usability Scale (SUS).

  4 weeks

• Mean time required for procedure.

  4 weeks

• Pain related to procedure (Group A and B).

  4 weeks

Study Arms (1)

Evaluate the harvesting of micografts in healthy and patients with chronic wounds

EXPERIMENTAL

The ART Skin Harvesting System is intended to harvest full thickness skin microcolumns in a minimally invasive manner and scatter them at the recipient site. It consists of three components: (1) a non-sterile, reusable handheld device; (2) a sterile, single-patient use needle cartridge containing the needle array for harvesting skin micrografts from the patient donor site; and (3) a sterile, disposable handheld protective sleeve to cover the handheld device (figure 1). The sterile sleeve reduces contamination of the reusable handheld device and provides a sterile barrier between the non-sterile handheld device and the patient.

Device: Autologous Regeneration of Tissue (ARTTM) system

Interventions

Autologous Regeneration of Tissue (ARTTM) system DEVICE

The ART Skin Harvesting System is intended to harvest full thickness skin microcolumns in a minimally invasive manner and scatter them at the recipient site. It consists of three components: (1) a non-sterile, reusable handheld device; (2) a sterile, single-patient use needle cartridge containing the needle array for harvesting skin micrografts from the patient donor site; and (3) a sterile, disposable handheld protective sleeve to cover the handheld device (figure 1). The sterile sleeve reduces contamination of the reusable handheld device and provides a sterile barrier between the non-sterile handheld device and the patient.

Evaluate the harvesting of micografts in healthy and patients with chronic wounds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group A (Healthy Individuals)
• years or older.
• Healthy participants without major diseases.
• Group B (Subjects with Chronic Wounds)
• Participants presenting with chronic wound(s) present for a minimum of 4 weeks (eg. diabetic foot ulcers (DFU), venous leg ulcers (VLU), pressure ulcers (PrU), and other acceptable etiologies).
• years or older.

You may not qualify if:

• Subject on an investigational drug or therapeutic device within 30 days of the study visit.
• Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
• Known allergy to any of the dressings or their components.
• The subject has a history of excessive bleeding.
• The subject has a history of keloid formation.

Sponsors & Collaborators

• SerenaGroup, Inc.: lead
• Medline Industries: collaborator

Study Sites (1)

SerenaGroup - Monroeville

Monroeville, Pennsylvania, 15146, United States

Location

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Thomas Serena, MD,FACS

  SerenaGroup, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The ARTTM system is an electrically powered handheld device containing disposable sterile needle cartridges. The control elements include a push button that operates the back and forth movement of the needles in the cartridge. The device can harvest over 300 full thickness MicroColumns.

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: October 13, 2021
• Study Start: September 13, 2021
• Primary Completion: November 22, 2021
• Study Completion: February 1, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)