Non-Surgical Rhinoplasty Using PDO Threads

NCT04769427 | Completed FDA Device

• 1 other identifier: PDO-122020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effects of absorbable Polydioxanone (PDO) thread non-surgical revision rhinoplasty on first impressions and quality of life (FACE-Q scale) in 10 patients who desire further changes to their nasal tip and/or nasal dorsum

Conditions

Nasal Defect

Outcome Measures

Primary Outcomes (1)

• Non -surgical rhinoplasty using PDO Max threads

  The effects of absorbable Polydioxanone (PDO) thread non-surgical rhinoplasty on quality of life (FACE-Q scale). FACE-Q scales are rated from 1-4 with ratings closer to 4 as more favorable.

  1 month

Secondary Outcomes (2)

• Non -surgical rhinoplasty using PDO Max threads

  1 month

• Non -surgical rhinoplasty using PDO Max threads

  1 month

Study Arms (1)

PDO Max thread injection to nose

EXPERIMENTAL

Device: PDO max threads

Interventions

PDO max threads DEVICE

To determine the effects of absorbable Polydioxanone (PDO) thread non-surgical rhinoplasty on quality of life (FACE-Q scale)

PDO Max thread injection to nose

Eligibility Criteria

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

You may qualify if:

• Males and females of ages 18 and above.
• Subjects will be required not to have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
• Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit.

You may not qualify if:

• Males and females below age of 18.
• Subjects who have had previous surgery, filler injections, or other cosmetic treatments to the nose within the last 12 months.
• Patients with any prior nasal implants
• Subjects who are pregnant or nursing.
• Subjects with a known allergy or sensitivity to any component of the study ingredients.
• Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
• Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
• Subjects with diseases, injuries, or disabilities of the nose, including those with autoimmune disease affecting the nose
• Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded.

Sponsors & Collaborators

• DeNova Research: lead

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

Study Design

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

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: February 24, 2021
• Study Start: January 20, 2021
• Primary Completion: June 9, 2021
• Study Completion: October 10, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

US (1)