NCT03756688|CompletedResultsFDA Device
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Sponsor study identifier
interventional
110
1 country
1
Study Start
November 7, 2018
Actual (reported)Primary Completion
March 18, 2021
Actual (reported)Study Completion
March 18, 2021
Actual (reported)The objective of the current study is to evaluate the efficacy of a novel penile traction device in restoring lost penile length in men with type 2 diabetes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 18, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 7, 2018
Actual (reported)November 24, 2018
Actual (reported)November 28, 2018
Actual (reported)March 18, 2021
Actual (reported)March 18, 2021
Actual (reported)February 21, 2023
Actual (reported)Penile Length Change Between Baseline and Month 6
Primary objective of this study is to assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of Diabetes Type II patients. Measurements were obtained at baseline and 6 months post-prostatectomy.
Baseline to 6 months
Patient Compliance With Traction Therapy
6 months
Patient Reported Satisfaction With Traction Therapy at 6 Months.
6 months
Number of Participants With Adverse Events With Use of RestoreX
3 and 6 months post-prostatectomy
Number of Participants With De-novo Peyronie's Disease Development
6 months
Subjective Comparison of Changes in Penile Length
6 months
No treatment will be administered for the entirety of the study (6 months)
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
Penile traction therapy in straight position for all 6 months.
Penile traction therapy in straight position for first phase (3 months)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Matthew Ziegelmann, MD
Mayo Clinic
110 participants (actual enrollment reported by the registry).
First Submitted
November 24, 2018
First Posted
Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes
PTT for 30 min 2x day x 6 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
November 28, 2018
Study Start
November 7, 2018
Actual (reported)Primary Completion
March 18, 2021
Actual (reported)Study Completion
March 18, 2021
Actual (reported)Last Updated
February 21, 2023
Results First Posted
February 21, 2023
Record last verified: 2023-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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