Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Erectile Dysfunction
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective, multi-center, two-arm, blinded, randomized treatment. Covariate adaptive randomization will be used. Covariates included in the adaptive randomization process will be investigational center, history of diabetes, and radical prostatectomy.Masking: Single (Participant)Masking Description: Sham treatmentPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Only males
Description
Prospective, multi-center, two-arm, blinded, randomized treatment. Covariate adaptive randomization will be used. Covariates included in the adaptive randomization process will be investigational center, history of diabetes, and radical prostatectomy. The two randomized study arms are: Treatment wit...
Prospective, multi-center, two-arm, blinded, randomized treatment. Covariate adaptive randomization will be used. Covariates included in the adaptive randomization process will be investigational center, history of diabetes, and radical prostatectomy. The two randomized study arms are: Treatment with SVF followed six months later with sham treatment (ARM 1) Sham treatment followed six months later by treatment with SVF (ARM 2) Study population is 60 adult male subjects with organic erectile dysfunction (IIEF-EF score 11-22) of greater than 6 months' duration due to radical prostatectomy, diabetes mellitus, and/or vascular disease. Subjects will be followed for 12 months after initial treatment.
Tracking Information
- NCT #
- NCT03518333
- Collaborators
- Not Provided
- Investigators
- Study Chair: Paul Kosnik, PhD Sponsor GmbH
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