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Quantitative Assessment of Autologous Fat Transfer

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
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Record History

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  1. Primary and study completion pushed from Dec 2026 to Dec 2027
    • Primary endpoints: details revised at 1 of 1 entry
    • Interventions: 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6) (Procedure), 3-Dimensional (3-D) Photographs (Visit 1- 6) (Procedure)… to 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6) (Procedure), 3-Dimensional (3-D) Photographs (Visit 1- 6) (Procedure)…
    • Eligibility criteria expanded, about 6 words
  2. Primary completion date: Dec 2025 to Dec 2026v4
  3. Study sites: 1 to 2v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2024 to Jan 25, 2024
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing Autologous Fat Transfer (AFT) for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, Magnetic resonance imaging (MRI), and Ultrasound (US) are routinely used in practice but will be performed for research purposes in this study. All imaging procedures and questionnaires will be obtained at baseline and follow-up visits 3-6.
Trial Details
NCT Number NCT06343831
Lead Sponsor University of Chicago
Collaborators: National Institutes of Health (NIH), University of Houston
Conditions
(from sponsor)		 Autologous Fat Grafting
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov