Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04533373 · ClinicalTrials.gov registry record · NA
Sensory Restoration After DIEP Flap Neurotization
A NA study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- NA
- Development phase
- 156
- Enrollment target
NCT04533373: Clinical Trial NA study, sponsored by Johns Hopkins University.
NCT04533373 is a NA study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 156 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04533373, a NA study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- NA
- Development phase
- 156 participants
- Enrollment target
Study Summary
Common goals of breast reconstruction include obtaining satisfactory breast symmetry, softness, and appropriate size and shape. Advances in surgical techniques have prompted a new goal: achieving breast sensation after reconstructive surgery. This desire has led the surgical community to investigate operative techniques for achieving this goal. However, few studies have examined the effectiveness of breast sensory restoration. Sensory nerves are nerves responsible for sensation from skin. When a sensory nerve is cut, sensation is lost to the area supplied by the nerve. In the case of Breast reconstruction this involves the nerves supplying the skin overlying breast(s). 'Neurotization' refers to regeneration of the nerve after it has been cut. This means that the cut nerve is being repaired in order to restore its function. In Neurotization this repair is carried out using a new "source". In this case, the investigators want to restore function of the nerves that supply the skin overlying the breast(s). The investigators will be performing breast reconstruction using tissue from the patient's abdomen and transferring it to the chest wall to repair the mastectomy defect. Sensory function is restored by using the nerve that supplies the skin of this abdominal tissue (i.e the new "source") that is being transferred and attaching it to a nerve in the chest wall. The Avance® Nerve graft is a nerve graft material that has been produced by Axogen, Inc. The graft is made by processing donated human nerves. This graft is used during neurotization to bridge the gap and join the nerve from the abdominal tissue to the nerve in the chest wall. The use of the graft helps the body to attach these 2 nerves and improves nerve repair. When neurotization is done without the nerve graft there is a possibility that the surgeon may require extra nerve material to join the 2 nerves. Traditionally, in this case the surgeon would have to obtain a separate donor nerve from another part of
Primary Outcome
Breast sensation, measured in cutaneous thresholds using the AcroValTM device.
Interventions
- PROCEDURE DIEP Flap Neurotization
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2024-09-11 |
| Phase | NA |
Why NCT04533373 stopped before completion
NCT04533373 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which DIEP Flap Neurotization is the first listed.
NCT04533373 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04533373 about?
NCT04533373 is a clinical study titled "Sensory Restoration After DIEP Flap Neurotization". Common goals of breast reconstruction include obtaining satisfactory breast symmetry, softness, and appropriate size and shape. Advances in surgical techniques have prompted a new goal: achieving breast sensation after reconstructive surgery. This desire has led the surgical community to investigate...
What is the current status of trial NCT04533373?
This trial is currently terminated. It is a NA study. The enrollment target is 156 participants. The study started on 2020-12-01. Estimated completion is 2024-09-11.
What interventions are being tested in trial NCT04533373?
The interventions under investigation include: DIEP Flap Neurotization (PROCEDURE).
Who is sponsoring clinical trial NCT04533373?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04533373's enrollment target sits among peer trials
156 656th of 2000 higher than 1,345 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03082755 · 156 participants · Phase 4
Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
- NCT04047628 · 156 participants · Phase 3
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
- NCT04166877 · 156 participants · Phase 4
Magnesium Infusion for Pain Management in Critically Ill Trauma Patients
- NCT04533464 · 156 participants · Phase 2
MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI