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NCT03584022 · ClinicalTrials.gov registry record · NA
Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
A NA study of Amyloidosis and Peripheral Neuropathy, sponsored by Mayo Clinic.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03584022: Active NA study of Amyloidosis and Peripheral Neuropathy, sponsored by Mayo Clinic.
NCT03584022 is a NA study of Amyloidosis and Peripheral Neuropathy that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 20 participants, below the 1,128-participant average among 28 other Amyloidosis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03584022, a NA study of Amyloidosis and Peripheral Neuropathy, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This is safety study. Subjects will be undergoing the surgical procedure of nerve biopsy. After routine surgery without grafting, patients develop swelling, redness, tenderness and dysesthesia at the biopsy site. In order to determine whether grafting is safe compared to not repairing the nerve, it is necessary to compare treated vs. untreated patients using systematic, sensitive and reproducible criteria.
Primary Outcome
Post-surgical reactions will include evaluations of the following: 1. Percussion tenderness at site of proximal stump or repair site; 2. Skin redness at the site of biopsy (length and width measured with calipers); 3. Development of mild or moderate swelling along the site (yes or no). It is anticipated that this will resolve to a lower grade or progress to grade 4. 4. Development of severe swelling or pustules or evidence of tube extrusion or wound dehiscence.
Conditions Studied
Interventions
- DEVICE Biopsy + Nerve Repair
- PROCEDURE Biopsy Only
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-11-09 |
| Est. Completion | 2027-03 |
| Phase | NA |
What the registry record for NCT03584022 still lists
NCT03584022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,128-participant average among 28 other Amyloidosis trials with a reported enrollment target (98% lower).
The record links to 6 conditions, with Amyloidosis appearing as the primary indexed condition, and to 2 interventions - of which Biopsy + Nerve Repair is the first listed.
NCT03584022 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03584022 about?
NCT03584022 is a clinical study titled "Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial". This is safety study. Subjects will be undergoing the surgical procedure of nerve biopsy. After routine surgery without grafting, patients develop swelling, redness, tenderness and dysesthesia at the biopsy site. In order to determine whether grafting is safe compared to not repairing the nerve, it ...
What is the current status of trial NCT03584022?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2018-11-09. Estimated completion is 2027-03.
What conditions does trial NCT03584022 study?
This clinical trial studies the following conditions: Amyloidosis, Peripheral Neuropathy, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Vasculitic Neuropathy (Disorder), Hereditary Neuropathy.
What interventions are being tested in trial NCT03584022?
The interventions under investigation include: Biopsy + Nerve Repair (DEVICE), Biopsy Only (PROCEDURE).
Who is sponsoring clinical trial NCT03584022?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03584022 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03584022's enrollment target sits among peer trials
20 26th of 28 higher than 1 of 28 other Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyloidosis 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.
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