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Cryopreserved Umbilical Cord Graft + Robotic Surgery for Prostate Cancer
Phase 2 & 3
Recruiting
Led By Michael Stifelman, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled to undergo bilateral, nerve-sparing RARP
Male aged between 30 and 70 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post op
Awards & highlights
Study Summary
This trial will test if a new surgical technique can help reduce the time it takes for men to recover sexual and urinary function after surgery for prostate cancer.
Who is the study for?
Men aged 30-70 with organ-confined prostate cancer, no erectile dysfunction, and good urinary function are eligible. They must be scheduled for nerve-sparing robotic prostatectomy, agree to follow-up visits and instructions, and have not had certain prior treatments or surgeries.Check my eligibility
What is being tested?
The study tests if using CLARIX® CORD 1K during robot-assisted radical prostatectomy can speed up the return of complete erectile and urinary function post-surgery. Participants will provide feedback on their sexual and urinary health after the procedure.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, typical risks may include surgical complications like infection or bleeding, reaction to materials used in surgery (CLARIX® CORD), and potential delays in recovery of erectile/urinary functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a prostate surgery that preserves nerve function.
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I am a man aged between 30 and 70.
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My prostate cancer has not spread beyond the prostate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Erectile function
Secondary outcome measures
Biochemical recurrence endpoint
Failure Events of Following RARP endpoint
Pad Count
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CLARIX CORD 1KExperimental Treatment2 Interventions
They will receive adjunctive CLARIX® CORD 1K (Amniox Medical, Inc., Miami, FL) during Robot-Assisted Radical Prostatectomy (RARP).
Group II: ControlsActive Control1 Intervention
They will undergo RARP without adjunctive CLARIX® CORD 1K.
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Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,144 Total Patients Enrolled
1 Trials studying Prostate Cancer
600 Patients Enrolled for Prostate Cancer
Michael Stifelman, MDPrincipal InvestigatorChair of Urology Department
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy to my pelvic area before.I have not had pelvic surgery in the last 5 years, except for hernia repair.I have a condition where my bladder doesn't function properly due to nerve damage.I am scheduled for a prostate surgery that preserves nerve function.I have had systemic therapy for prostate cancer before.I have had surgery for prostate issues before.I weigh less than 110 pounds or my BMI is over 40.I am scheduled for cancer treatment like chemotherapy or surgery during the study.I do not have any neurological or psychiatric conditions that could affect surgery outcomes.I am a man aged between 30 and 70.My prostate cancer has not spread beyond the prostate.
Research Study Groups:
This trial has the following groups:- Group 1: Controls
- Group 2: CLARIX CORD 1K
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project have an age limit?
"Participants must be aged 30 to 70 in order to enrollment in this clinical trial."
Answered by AI
Who would be able to enroll and participate in this clinical trial?
"To be eligible for this prostate cancer study, men must be between 30 and 70 years old with primary organ confined prostate cancer. Additionally, they cannot have any form of erectile dysfunction (IIEF-6 score ≥ 26) and must be willing to return for follow up visits. Finally, patients must provide written informed consent."
Answered by AI
Are new participants being accepted into this research project?
"Yes, this is still an ongoing study that is actively recruiting patients, as of November 15th, 2020. The clinical trial was first posted on January 30th, 2020."
Answered by AI
How many individuals are enrolled in this research project?
"The listing on clinicaltrials.gov verifies that this experiment is looking for volunteers at this time. It was originally posted on 1/30/2020, with the most recent update being 11/15/2022. They are hoping to have 100 people participate from 2 different locations."
Answered by AI
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