Erectile DysfunctionNCT03039218
Dornier Aries 2 Extracorporeal Shock Wave Device for the Treatment of Mild Erectile Dysfunction (ED)
A study testing Dornier Aries 2 in people with Erectile Dysfunction, run by Dornier MedTech Systems at 4 sites in United States.
Trial summary
This protocol allows for treatment of 100 men in two groups (placebo and active treatment) of 22-70 years of age with mild (IIEF EF of 17 to 25 at baseline) vasculogenic erectile dysfunction of at least 6 months duration with low intensity extracorporeal shock wave therapy utilizing the Dornier Aries 2 device. Read more about this study
- Who is it for?
- Ages 22 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Dornier Aries 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Feb 2017to 29 Mar 2018
- 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 22 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent to participate.
- Age 22-70 years.
- Presence of Vasculogenic Erectile Dysfunction for at least 6 months.
- Having some response to a PDE5i. Last PDE5i use must be within 30 days of Screening Visit.
- IIEF-EF score ≥17 up to ≤30 while taking PDE5i.
- IIEF-EF score ≥17 up to ≤25 after wash out of PDE5i.
Show all 9Show fewer
- In a stable heterosexual relationship of more than three months duration.
- Sexually active and agree to suspend all ED therapy for duration of study.
- Agree to maintain their normal sexual habits.
Who cannot join
- Radical prostatectomy.
- Previous radiation therapy to pelvis.
- Previous stem cell or platelet rich plasma therapy.
- Previous pelvic surgeries that in the judgment of the investigator could impact on erectile function such as radical prostatectomy, radical cystectomy, Peyronie's disease surgery, penile lengthening or penile cancer surgery.
- Untreated Hypogonadism as demonstrated by abnormal testosterone levels lower than 300 ng/dL.
- Hormone usage, other than testosterone, clomiphene or thyroid medication.
Show all 23Show fewer
- Use of cocaine, cannabinoids, opiates, barbiturates, amphetamines, or benzodiazepine as demonstrated in the drug screen.
- Psychogenic ED.
- Peyronie's Disease or penile curvature that negatively influences sexual activity.
- Current anticoagulation therapy or significant hematological conditions as demonstrated in abnormal values in the complete blood count.
- Liver disease as demonstrated by abnormal chemistry panel or coagulation values in the prothrombin time (PT) along with its derived measures of prothrombin ratio (PR) blood tests.
- Abnormal serum testosterone level defined as a value lower than 300 ng/dL or greater than 1197 ng/dL.
- Patients with cardiac or non-cardiac electrical devices implanted.
- Anatomical or neurological abnormalities in the treatment area.
- Diabetes Mellitus with severe polyneuropathy.
- Patients with generalized polyneuropathy irrespective of cause.
- Refusal to suspend ED therapy for duration of study.
- Men deemed not healthy enough to participate in sexual activity.
- IIEF-EF score of 0-16 or higher than 25 at baseline assessment following "washout" period.
- Average EHS ≤ 2 at baseline assessment following "washout".
- Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
- Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study.
- Known allergy to ultrasound gel.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brooklyn Urology Research Group
Brooklyn, New York, 11215
Manhattan Medical Research
New York, New York, 10016
Adult Pediatric Urology & Urogynecology
Omaha, Nebraska, 68114
San Diego Sexual Medicine
San Diego, California, 92120
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Open-Label Extension Clinical Trial of the Dornier Aries 2 Extracorporeal Shock Wave Device for the Treatment of Mild Erectile Dysfunction (ED)
This protocol allows for treatment of 100 men in two groups (placebo and active treatment) of 22-70 years of age with mild (IIEF EF of 17 to 25 at baseline) vasculogenic erectile dysfunction of at least 6 months duration with low intensity extracorporeal shock wave therapy utilizing the Dornier Aries 2 device.
Read the detailed description
This trial is a prospective, randomized, placebo-controlled, double-blind pivotal study, with an open-label extension. The study will include 4 sites and multiple investigators. A total of 100 men with at least a 6-month history of ED and who have responded to PDE5 inhibitors will be enrolled. The trial comprises two arms to achieve equal characteristics, where patients are randomly assigned to active treatment or sham treatment.
All patients on active treatment will receive LI-ESWT treatment using the Dornier Aries 2. Patients assigned to the placebo group will receive the Dornier Aries 2 treatment using a sham applicator. The time between two treatments is 6-7 days to allow for angiogenesis and perfusion improvements to occur. The subjects' duration of participation will be a total of 34 weeks Subjects will also be asked to maintain their current level of sexual activity while participating in the study.
- Conditions
- Erectile Dysfunction
- Being tested
- Dornier Aries 2, Placebo / Sham
- Keywords
- erectile dysfunction, shockwave, Dornier
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dornier Aries 2Device
Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction
Placebo / ShamDevice
Inactive (placebo/sham) Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Subjects assigned to this group will receive Active treatments using the Dornier Aries 2. Receives: Device: Dornier Aries 2 |
| Placebo / Sham | Placebo comparator | Subjects assigned to this group will receive placebo / sham (no active treatment). Receives: Device: Placebo / Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Inventory of Erectile Function ("IIEF")
validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials
Measured: primary outcome at 3 month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start7 Feb 2017
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Why it stopped: Commercial decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- A total of 100 subjects will be randomized to either the Active or Sham/Placebo group. Following completion of the 3 month follow-up visit, subjects will be unblinded. Subjects who received the Placebo/Sham treatment will be offered treatment using the Active device applicator.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dornier MedTech Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irwin Goldstein, Principal investigator, San Diego Sexual Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039218
- Sponsor's protocol ID
- G140216 S004
- Status last verified
- Aug 2018
- First submitted
- 26 Jan 2017
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual patient data will not be shared with other researchers.
Publications
Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13.
PubMed 27986492Angulo JC, Arance I, de Las Heras MM, Meilan E, Esquinas C, Andres EM. Efficacy of low-intensity shock wave therapy for erectile dysfunction: A systematic review and meta-analysis. Actas Urol Esp. 2017 Oct;41(8):479-490. doi: 10.1016/j.acuro.2016.07.005. Epub 2016 Aug 10. English, Spanish.
PubMed 27521134Zou ZJ, Liu ZH, Tang LY, Lu YP. Is there a role for extracorporeal shock wave therapy for erectile dysfunction unresponsive to phosphodiesterase type 5 inhibitors? World J Urol. 2017 Jan;35(1):167-171. doi: 10.1007/s00345-016-1899-y. Epub 2016 Jul 22. No abstract available.
PubMed 27447990Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis. Eur Urol. 2017 Feb;71(2):223-233. doi: 10.1016/j.eururo.2016.05.050. Epub 2016 Jun 16.
PubMed 27321373Kitrey ND, Gruenwald I, Appel B, Shechter A, Massarwa O, Vardi Y. Penile Low Intensity Shock Wave Treatment is Able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study. J Urol. 2016 May;195(5):1550-1555. doi: 10.1016/j.juro.2015.12.049. Epub 2015 Dec 13.
PubMed 26694904
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Open-Label Extension Clinical Trial of the Dornier Aries 2 Extracorporeal Shock Wave Device for the Treatment of Mild Erectile Dysfunction (ED)
- ClinicalTrials.gov ID
- NCT03039218
- Acronym / sponsor ID
- G140216 S004
- Conditions
- Erectile Dysfunction
- Keywords
- erectile dysfunction, shockwave, Dornier
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Commercial decision
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Dornier MedTech SystemsIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 1 Feb 2017 (estimated)
- 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 protocol allows for treatment of 100 men in two groups (placebo and active treatment) of 22-70 years of age with mild (IIEF EF of 17 to 25 at baseline) vasculogenic erectile dysfunction of at least 6 months duration with low intensity extracorporeal shock wave therapy utilizing the Dornier Aries 2 device.
Detailed description
This trial is a prospective, randomized, placebo-controlled, double-blind pivotal study, with an open-label extension. The study will include 4 sites and multiple investigators. A total of 100 men with at least a 6-month history of ED and who have responded to PDE5 inhibitors will be enrolled. The trial comprises two arms to achieve equal characteristics, where patients are randomly assigned to active treatment or sham treatment.
All patients on active treatment will receive LI-ESWT treatment using the Dornier Aries 2. Patients assigned to the placebo group will receive the Dornier Aries 2 treatment using a sham applicator. The time between two treatments is 6-7 days to allow for angiogenesis and perfusion improvements to occur. The subjects' duration of participation will be a total of 34 weeks Subjects will also be asked to maintain their current level of sexual activity while participating in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A total of 100 subjects will be randomized to either the Active or Sham/Placebo group. Following completion of the 3 month follow-up visit, subjects will be unblinded. Subjects who received the Placebo/Sham treatment will be offered treatment using the Active device applicator.
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Dornier Aries 2Subjects assigned to this group will receive Active treatments using the Dornier Aries 2. |
| Placebo / Sham | Placebo comparator | Device: Placebo / ShamSubjects assigned to this group will receive placebo / sham (no active treatment). |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Consent to participate.
- Age 22-70 years.
- Presence of Vasculogenic Erectile Dysfunction for at least 6 months.
- Having some response to a PDE5i. Last PDE5i use must be within 30 days of Screening Visit.
- IIEF-EF score ≥17 up to ≤30 while taking PDE5i.
Key exclusion criteria (23 listed)
- Radical prostatectomy.
- Previous radiation therapy to pelvis.
- Previous stem cell or platelet rich plasma therapy.
- Previous pelvic surgeries that in the judgment of the investigator could impact on erectile function such as radical prostatectomy, radical cystectomy, Peyronie's disease surgery, penile lengthening or penile cancer surgery.
- Untreated Hypogonadism as demonstrated by abnormal testosterone levels lower than 300 ng/dL.
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 |
|---|---|---|
| Dornier Aries 2Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction | Device | Active |
| Placebo / ShamInactive (placebo/sham) Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction | Device | Placebo / Sham |
Primary outcome
International Inventory of Erectile Function ("IIEF")
Time frame: primary outcome at 3 month follow-up visit
validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials
Results and safety
The study was stopped early (reason given: Commercial decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Results publication: PubMed 27986492Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13.
- Results publication: PubMed 27521134Angulo JC, Arance I, de Las Heras MM, Meilan E, Esquinas C, Andres EM. Efficacy of low-intensity shock wave therapy for erectile dysfunction: A systematic review and meta-analysis. Actas Urol Esp. 2017 Oct;41(8):479-490. doi: 10.1016/j.acuro.2016.07.005. Epub 2016 Aug 10. English, Spanish.
- Results publication: PubMed 27447990Zou ZJ, Liu ZH, Tang LY, Lu YP. Is there a role for extracorporeal shock wave therapy for erectile dysfunction unresponsive to phosphodiesterase type 5 inhibitors? World J Urol. 2017 Jan;35(1):167-171. doi: 10.1007/s00345-016-1899-y. Epub 2016 Jul 22. No abstract available.
- Results publication: PubMed 27321373Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis. Eur Urol. 2017 Feb;71(2):223-233. doi: 10.1016/j.eururo.2016.05.050. Epub 2016 Jun 16.
- Results publication: PubMed 26694904Kitrey ND, Gruenwald I, Appel B, Shechter A, Massarwa O, Vardi Y. Penile Low Intensity Shock Wave Treatment is Able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study. J Urol. 2016 May;195(5):1550-1555. doi: 10.1016/j.juro.2015.12.049. Epub 2015 Dec 13.
- Individual participant dataSharing planned: No. Individual patient data will not be shared with other researchers.
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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.
Irwin Goldstein principal investigator
San Diego Sexual Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dornier Aries 2 in people with Erectile Dysfunction, run by Dornier MedTech Systems at 4 sites 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 23 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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: Commercial 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?
International Inventory of Erectile Function ("IIEF") (time frame: primary outcome at 3 month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03039218, which also lists 5 linked publications.
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 17 Aug 2018.