MedTrace Logo

Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products

NCT06093815 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-12-13

No results posted yet for this study

Summary

The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints. The study will also provide tissue specimens which will be used in a subsequent study.

Safety endpoint: incidence of adverse events.

Conditions

  • Injection Site Reaction

Interventions

DEVICE

Injection

A pre specified amount will be injected in tissue at selected timepoints

Sponsors & Collaborators

  • Merz North America, Inc.

    lead INDUSTRY

Principal Investigators

  • Ann P Marx, MD · Merz North America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-09-08
Primary Completion
2024-05-01
Completion
2024-11-01
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

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 NCT06093815 on ClinicalTrials.gov