Erectile DysfunctionNCT05196191
Wound Healing Following Penile Prosthesis Implant
A study testing VIAGENEX Max and Hibiclens wash in people with Erectile Dysfunction, run by VIVEX Biologics, Inc. at 1 site in United States.
Trial summary
This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on men undergoing penile implant surgery for the first time. The patients are randomized in a 2:1 ratio of active to sham treatment groups. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- VIAGENEX Max and Hibiclens wash
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient must be willing and able to provide informed consent
- The patient is a male between >/= 30 and =/< 70 years of age
- The patient has ED based of International Index of Erectile Dysfunction (IIEF) scores
- The patient has been in a stable relationship for over 3 months prior to enrollment
- A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by IIEF
- The patient is suffering from erectile dysfunction and undergoing penile implant surgery for the first time
Show all 9Show fewer
- IIEF-EF score between 16 and 25
- Testosterone level 300-1000 ng/dL within 1 month prior to enrollment
- A1C level </= 7% within 1 month prior to enrollment
Who cannot join
- The patient is currently or has participated in another study within the past three months that may interfere with the results or conclusions of this study
- The patient is under judicial protection (prison or custody)
- The patient is an adult under guardianship
- The patient refuses to sign the consent
- History of radical prostatectomy or extensive pelvic surgery
- Evidence of venous leak
Show all 15Show fewer
- Past radiation therapy of the pelvic region within 12 months prior to enrollment
- Recovering from any cancer within 12 months prior to enrollment
- Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function at the discretion of the investigator
- Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator
- Anatomical malformation of the penis, including Peyronie's disease
- Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment
- A1C level > 7% within 1 month prior to enrollment or history of insulin dependent diabetes
- The patient is taking blood thinners and has an international normalized ratio >3
- Received shockwave treatment at least 6 months before enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of Vivex Tissue for Accelerated Wound Healing Following Penile Prosthesis Placement With Follow-up
This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on men undergoing penile implant surgery for the first time. The patients are randomized in a 2:1 ratio of active to sham treatment groups.
Read the detailed description
Erectile Dysfunction (ED) is a condition with an inability to develop or maintain an erection of the penis upon sexual stimulation. It occurs in association with aging, chronic illnesses and various modifiable risk factors. Amongst the modifiable risk factors, ED shares the most common risk factors with Coronary Artery Disease (CAD) which are smoking, hypertension and hyperlipidemia. Even though it is not a part of normal aging, it is seen in 52% of men in the age group 40 to 70 years, with a higher rate in the men more than 70 years.
VIAGENEX Max is a semi-transparent, collagenous membrane intended for soft tissue barrier or wound covering, derived from umbilical cord membrane. A total of 50 subjects with ED meeting the eligibility criteria will be randomized. The treatment graft will be placed into the wound at time of surgery. The treatment group will receive the VIAGENEX graft and the sham group will receive the standard of care for this surgery.
- Conditions
- Erectile Dysfunction
- Being tested
- VIAGENEX Max, Hibiclens wash
- Keywords
- Viagenex Max, penile implant, erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIAGENEX MaxBiological
Collagenous membrane derived from umbilical cord
Hibiclens washProcedure or surgery
Antiseptic skin cleanser
| Study group | Role | What they receive |
|---|---|---|
| Viagenex Max | Experimental | VIAGENEX Max graft will be placed in the incision at the end of surgery prior to closing. Receives: Biological: VIAGENEX Max |
| Standard of care | Active comparator | Hibiclens wash will be performed. Receives: Procedure: Hibiclens wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile implant activation
Time to use implant for sexual activity
Measured: up to 3 months
Secondary outcomes (1)
Pain after undergoing penile prosthesis surgery
Numerical pain scale (0=no pain to 10=worst pain) used to
Measured: surgery to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start3 Jan 2022
- Primary completion13 Dec 2023
- Study completion30 Dec 2023
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects meeting criteria will be randomized 4:1 treatment (Viagenex Max) or sham (standard of care).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVEX Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tariq Hakky, MD, Principal investigator, Atlanta Cosmetic Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196191
- Sponsor's protocol ID
- CYG-2021-001
- Status last verified
- Feb 2024
- First submitted
- 14 Dec 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Vivex Tissue for Accelerated Wound Healing Following Penile Prosthesis Placement With Follow-up
- ClinicalTrials.gov ID
- NCT05196191
- Acronym / sponsor ID
- CYG-2021-001
- Conditions
- Erectile Dysfunction
- Keywords
- Viagenex Max, penile implant, erectile dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 32 participants (actual)
- Lead sponsor
- VIVEX Biologics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on men undergoing penile implant surgery for the first time. The patients are randomized in a 2:1 ratio of active to sham treatment groups.
Detailed description
Erectile Dysfunction (ED) is a condition with an inability to develop or maintain an erection of the penis upon sexual stimulation. It occurs in association with aging, chronic illnesses and various modifiable risk factors. Amongst the modifiable risk factors, ED shares the most common risk factors with Coronary Artery Disease (CAD) which are smoking, hypertension and hyperlipidemia. Even though it is not a part of normal aging, it is seen in 52% of men in the age group 40 to 70 years, with a higher rate in the men more than 70 years.
VIAGENEX Max is a semi-transparent, collagenous membrane intended for soft tissue barrier or wound covering, derived from umbilical cord membrane. A total of 50 subjects with ED meeting the eligibility criteria will be randomized. The treatment graft will be placed into the wound at time of surgery. The treatment group will receive the VIAGENEX graft and the sham group will receive the standard of care for this surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects meeting criteria will be randomized 4:1 treatment (Viagenex Max) or sham (standard of care).
| Arm | Type | Receives |
|---|---|---|
| Viagenex Max | Experimental | Biological: VIAGENEX MaxVIAGENEX Max graft will be placed in the incision at the end of surgery prior to closing. |
| Standard of care | Active comparator | Procedure: Hibiclens washHibiclens wash will be performed. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient must be willing and able to provide informed consent
- The patient is a male between >/= 30 and =/< 70 years of age
- The patient has ED based of International Index of Erectile Dysfunction (IIEF) scores
- The patient has been in a stable relationship for over 3 months prior to enrollment
- A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by IIEF
Key exclusion criteria (15 listed)
- The patient is currently or has participated in another study within the past three months that may interfere with the results or conclusions of this study
- The patient is under judicial protection (prison or custody)
- The patient is an adult under guardianship
- The patient refuses to sign the consent
- History of radical prostatectomy or extensive pelvic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIAGENEX MaxCollagenous membrane derived from umbilical cord | Biological | Viagenex Max |
| Hibiclens washAntiseptic skin cleanser | Procedure or surgery | Standard of care |
Primary outcome
Penile implant activation
Time frame: up to 3 months
Time to use implant for sexual activity
1 secondary outcome
Pain after undergoing penile prosthesis surgery
Time frame: surgery to 12 months
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No. IPD will not be shared.
Related trials for Erectile Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruiting
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
Prostate Cancer, Localized Prostate Carcinoma
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tariq Hakky, MD principal investigator
Atlanta Cosmetic Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIAGENEX Max and Hibiclens wash in people with Erectile Dysfunction, run by VIVEX Biologics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penile implant activation (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.