BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy
NCT ID: NCT05363644
Last Updated: 2023-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE3
INTERVENTIONAL
2023-04-01
2024-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
NCT05244486
Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy
NCT02961114
Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy
NCT06152146
Botulinum Toxin Injection With Prostate Brachytherapy
NCT00681148
Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy
NCT01566292
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
For the purpose of this study BioDFence® G3 will be placed on the neurovascular bundles by the surgeon during the robotic assisted radical prostatectomy procedure that the participant has elected as their primary treatment for prostate cancer. The potential benefits that will be assessed are an earlier return of potency after surgery as evidenced by The Sexual Health Inventory for Men (SHIM) questionnaire score and self-reported sexual function and secondarily looking at continence outcomes measured by The American Urological Association (AUA) questionnaire form and self-reported urinary function.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
No women, children or prisoners will be enrolled in this study.
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single Arm Study Group
Placement of a sheet of BioDFence G3 to the neurovascular bundle.
BioDFence G3
Placement of a sheet of BioDFence® G3 will be applied to the neurovascular bundle on participants undergoing an elective Full Nerve Sparing Radical Prostatectomy for primary treatment of prostate cancer.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BioDFence G3
Placement of a sheet of BioDFence® G3 will be applied to the neurovascular bundle on participants undergoing an elective Full Nerve Sparing Radical Prostatectomy for primary treatment of prostate cancer.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Primary diagnosis of prostate cancer requiring surgical intervention
3. Have a willingness to comply with follow-up requirements.
4. Have ability to provide full written consent.
5. Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, or 7.
6. Planned elective radical prostatectomy with bilateral full nerve sparing technique.
7. Patients who currently have a pre-operative SHIM \> 19
Exclusion Criteria
2. Has any condition(s), which seriously compromises the subject's ability to participate in this study or has a known history of poor adherence with medical treatment.
3. Has comorbid conditions that can be confused with or can exacerbate the condition of erectile dysfunction, including:
1. Diabetes Type I or Type II
2. Advanced atherosclerotic vascular disease
4. Is unable to sign or understand informed consent.
5. Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor.
6. Has a documented medical history of drug or alcohol abuse within last 12 months.
7. Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
8. Known sensitivity to glutaraldehyde or ethanol.
9. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
10. Has had prior hormonal therapy such as Lupron or oral anti-androgens.
11. Living outside of United States
12. Partial nerve sparing technique used during Radical Prostatectomy
40 Years
70 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Integra LifeSciences Corporation
INDUSTRY
AdventHealth
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vipul Patel, MD
Dr. Vipul R. Patel
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vipul R Patel, MD
Role: PRINCIPAL_INVESTIGATOR
AdventHealth
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AdventHealth
Celebration, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Shrader-Bogen CL, Kjellberg JL, McPherson CP, Murray CL. Quality of life and treatment outcomes: prostate carcinoma patients' perspectives after prostatectomy or radiation therapy. Cancer. 1997 May 15;79(10):1977-86. doi: 10.1002/(sici)1097-0142(19970515)79:103.0.co;2-r.
Walsh PC. Patient-reported urinary continence and sexual function after anatomic radical prostatectomy. J Urol. 2000 Jul;164(1):242. No abstract available.
Catalona WJ, Carvalhal GF, Mager DE, Smith DS. Potency, continence and complication rates in 1,870 consecutive radical retropubic prostatectomies. J Urol. 1999 Aug;162(2):433-8.
Rabbani F, Stapleton AM, Kattan MW, Wheeler TM, Scardino PT. Factors predicting recovery of erections after radical prostatectomy. J Urol. 2000 Dec;164(6):1929-34.
Stanford JL, Feng Z, Hamilton AS, Gilliland FD, Stephenson RA, Eley JW, Albertsen PC, Harlan LC, Potosky AL. Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: the Prostate Cancer Outcomes Study. JAMA. 2000 Jan 19;283(3):354-60. doi: 10.1001/jama.283.3.354.
Patel VR, Samavedi S, Bates AS, Kumar A, Coelho R, Rocco B, Palmer K. Dehydrated Human Amnion/Chorion Membrane Allograft Nerve Wrap Around the Prostatic Neurovascular Bundle Accelerates Early Return to Continence and Potency Following Robot-assisted Radical Prostatectomy: Propensity Score-matched Analysis. Eur Urol. 2015 Jun;67(6):977-980. doi: 10.1016/j.eururo.2015.01.012. Epub 2015 Jan 19.
Magatti M, De Munari S, Vertua E, Parolini O. Amniotic membrane-derived cells inhibit proliferation of cancer cell lines by inducing cell cycle arrest. J Cell Mol Med. 2012 Sep;16(9):2208-18. doi: 10.1111/j.1582-4934.2012.01531.x.
Wang TM. [Evaluation of the use of human amnion as a biological dressing]. Zhonghua Zheng Xing Shao Shang Wai Ke Za Zhi. 1986 Dec;2(4):282-3. No abstract available. Chinese.
DANFORTH D, HULL RW. The microscopic anatomy of the fetal membranes with particular reference to the detailed structure of the amnion. Am J Obstet Gynecol. 1958 Mar;75(3):536-47; discussion 548-50. doi: 10.1016/0002-9378(58)90610-0. No abstract available.
Walsh PC. Nerve grafts are rarely necessary and are unlikely to improve sexual function in men undergoing anatomic radical prostatectomy. Urology. 2001 Jun;57(6):1020-4. doi: 10.1016/s0090-4295(01)00987-6. No abstract available.
Menon M, Kaul S, Bhandari A, Shrivastava A, Tewari A, Hemal A. Potency following robotic radical prostatectomy: a questionnaire based analysis of outcomes after conventional nerve sparing and prostatic fascia sparing techniques. J Urol. 2005 Dec;174(6):2291-6, discussion 2296. doi: 10.1097/01.ju.0000181825.54480.eb.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1803935
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.