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First-in-Human Safety Study for Fractomer™ Biomatrix

NCT07151638 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-12-17

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety of implanting a new medical device (Fractomer™ Biomatrix) in healthy volunteers. The main question it aims to answer is:

How do healthy volunteers react to this injectable implant?

Participants will receive a subcutaneous injection of Fractomer and their health will be monitored. After the monitoring period, the implant will be removed.

Conditions

  • Soft Tissue
  • Soft Tissue Defects
  • Subcutaneous Injection

Interventions

DEVICE

Implantation (injection) of a new biomatrix for soft tissue support.

Implantation of a new injectable medical device, Fractomer Biomatrix, to study the safety of the product in healthy human participants.

Sponsors & Collaborators

  • inSoma Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Trisha Shamp, PhD, PA-C · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2025-10-22
Completion
2025-11-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07151638 on ClinicalTrials.gov