NCT07151638

First-in-Human Safety Study for Fractomer™ Biomatrix

Early Feasibility Trial for Fractomer™ Biomatrix: Safety Assessment in Healthy Human Participants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: inSoma Bio, Inc. · Industry
• Sex: All
• Age: 22 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This clinical trial is designed to establish the safety of a new injectable device, which may provide a more effective means of treating deformations or voids in soft tissue. Healthy volunteers will be implanted in the subcutaneous space in the abdominal area, and health measures will be periodically recorded. The device will be removed per the protocol time periods, and the removed specimens will be examined for histological analysis by a trained pathologist. All data will be reviewed to determine the safety of this implanted, bioresorbable device.

Conditions

• Soft Tissue
• Soft Tissue Defects
• Subcutaneous Injection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-11
• Primary completion: 2025-10-22
• Completion: 2025-11-05
• First posted: 2025-09-03
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study