# Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler

> **NCT04534660** · NA · COMPLETED · sponsor: **Sofregen Medical, Inc.** · enrollment: 21 (actual)

## Conditions studied

- Nasolabial Fold
- Cheek Augmentation

## Interventions

- **DEVICE:** SMI-01

## Key facts

- **NCT ID:** NCT04534660
- **Lead sponsor:** Sofregen Medical, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-11-10
- **Primary completion:** 2021-08-24
- **Final completion:** 2023-06-23
- **Target enrollment:** 21 (ACTUAL)
- **Last updated:** 2024-05-31

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04534660

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04534660, "Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT04534660. Licensed CC0.

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