Is NCT03258658 recruiting in Winston Salem, NC?

Yes, NCT03258658 is currently recruiting participants at its Winston Salem, NC location. This urologic diseases clinical trial is actively enrolling qualified participants.

How do I join the urologic diseases clinical trial in Winston Salem?

To join this clinical trial in Winston Salem, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Winston Salem clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Urologic Diseases Clinical Trial in Winston Salem, NC

About This Urologic Diseases Study in Winston Salem

This is a Phase I clinical study to determine the safety and efficacy of using autologous, engineered urethral constructs for the treatment of urethral strictures in adult males. The proposed study design is a prospective non-randomized and uncontrolled single-center investigation. Autologous urothelial cells (UCs) and smooth muscle cells (SMCs), obtained from enrolled male subjects' bladder tissue samples, will be culture expanded in vitro and used to seed tubular PGA scaffolds to create autologous urethral constructs for the repair of urethral strictures.

Sponsor: Wake Forest University Health Sciences

Who Can Participate

Inclusion Criteria

Stricture of the urethra meeting the following criteria: a) History of at least one 15-60 mm in length, as determined by urethrography. c) Contains at least 1 strictured segment through which a 16 Fr flexible cystoscope cannot be atraumatically passed.

Patients must be available for all follow-up visits.

Ability to speak English.

Exclusion Criteria

Strictures of the meatus or prostatic urethra; any urethral stricture associated with or suspected to be urethral carcinoma, or strictures due to pelvic distraction injuries. Strictures \<10 mm or \>60 mm, as determined by urethrography, and criteria for bulbar urethral strictures excluding those with strictures \<20 mm and \>60 mm, as described by urethrography.

Presence of untreated urinary tract infection.

Presence or prior history of lichen sclerosis et atrophicus (previously termed 'balanitis xerotica obliterans').

Uncontrolled bleeding disorder or patients with a platelet count less than 50,000, hemophilia or patients routinely receiving blood products for bleeding disorders.

Any urological condition that would be likely to require additional urethral instrumentation during the period of investigation, including, but not limited to benign prostatic hyperplasia requiring treatment, use of alpha blockers, active prostate cancer, an unevaluated elevated prostate surface antigen (PSA), bladder cancer, or any recurrent urinary stone formation. Patients with evidence or diagnosis of any coagulation disorder (including concomitant anti-coagulation therapy at enrollment).

Serum creatinine \> 2.0 mg/dl or evidence of progressive renal disease.

Patients with abnormal urologic conditions, including vesicoureteral reflux, bladder stones, bladder tumors and renal impairment.

Subjects with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>3 times the upper limit of normal.

Subjects with an albumin value \<3.0 g/dL.

Subjects with uncontrolled diabetes, unstable cardiac and/or pulmonary disorders.

Subjects with active tuberculosis (TB) requiring treatment in the past 3 years. Subjects with a current positive (≥5 mm induration for high-risk subjects; otherwise ≥10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment.

Subjects known to be colonized with either methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE), or gentamicin-resistant organisms.

Immunocompromised subjects or subjects receiving immunosuppressive agents (inhaled corticosteroids and chronic low-dose corticosteroids \[≤0.25 mg/kg prednisone or equivalent per day\] are permitted).

Any history of alcohol and/or drug abuse.

Current smoker.

Documented history of, or positive result of HIV, Hepatitis B or C, or any infectious disease. External signs, sequelae, or positive serology of sexually transmitted disease (including HPV).

Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study.

Concurrent participation in any other clinical investigation during the period of this investigation. Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study.

Any current illness that might confound the results of this investigation, including but not limited to bladder atonia, neuropathic/neurogenic bladder, bladder outlet obstruction (other than urethral stricture), sphincteric dysfunction, or spinal cord injury.

Any circumstance in which the investigator deems participation in the study is not in the subject's best interest.

Inability to participate in all necessary study activities due to physical or mental limitations.

Inability or unwillingness to return for all required follow-up visits.

inability or unwillingness to sign informed consent.

Patients requiring concomitant use of or treatment with immunosuppressive agents.

Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Winston Salem?

Yes, this clinical trial (NCT03258658) has an active research site in Winston Salem, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Urologic Diseases Treatment Options in Winston Salem, NC

If you're searching for urologic diseases treatment options in Winston Salem, NC, this clinical trial (NCT03258658) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Winston Salem research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced urologic diseases specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all urologic diseases clinical trials near you to find additional studies recruiting in your area.

Urologic Diseases Clinical Trial in Winston Salem, NC

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