Status:

COMPLETED

Non-Surgical Rhinoplasty Using PDO Threads

Lead Sponsor:

DeNova Research

Conditions:

Nasal Defect

Eligibility:

All Genders

18+ years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

January 20 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 10 2021

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT04769427

Start Date

January 20 2021

End Date

October 10 2021

Last Update

October 12 2021

Active Locations (1)

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DeNova Research

Chicago, Illinois, United States, 60611