fbpx

ED1000 treatment is performed in 75 different centres in Turkey.

Contact

Introduction of ED1000 Device

The ED1000 device is an innovative medical device designed to apply low intensity shock wave therapy (LI-ESWT). This device has been developed for use in the treatment of erectile dysfunction (ED).

Device Features

  • Portable and Lightweight: The device's compact and lightweight construction provides a user-friendly experience.
  • User Friendly: It offers ease of use with its easy-to-understand interface and control mechanism.
  • Safe: CE and FDA approvals are available and guarantee safe use.
  • Effective Treatment: Clinical trials have proven the effectiveness of the treatment.

The ED1000 device offers effective and reliable treatment, prioritising patient comfort.

Working Principles of ED1000 Device

The ED1000 device works by using low-intensity shock wave therapy (LI-ESWT). This treatment method is used to treat problems such as erectile dysfunction. The basic working principles are:

  • Application of shock waves: The ED1000 increases blood flow by applying treatment with low intensity shock waves.
  • Neovascularisation: Promotes the formation of new blood vessels (neovascularisation).
  • Targeted regions: It passes through the skin and reaches the targeted tissue areas.
  • Haemangiogenesis: Accelerates the re-formation of blood vessels.
  • Painless: No pain is usually felt during the treatment.
  • Minimum side effects: Side effects are rare and usually mild.

The effectiveness and reliability of the ED1000 is supported by clinical research.

Purpose and Importance of Clinical Research

Clinical trials are scientific studies to evaluate the effectiveness and safety of medical devices and treatments. The aim of these studies is to develop and improve the methods used in the treatment of various health problems. The following points stand out about the importance of clinical research with the ED1000 device:

  • Security: Determination of side effects and risks that may occur during the use of the device.
  • Event: To determine how effective the ED1000 device is in different patient groups.
  • Reproductivity Consistency of results across different researchers and settings.
  • Patient Satisfaction: Measurement of patients' satisfaction levels after treatment.

These factors play a critical role in the approval and dissemination of new treatment methods.

Use of ED1000 in the Treatment of Erectile Dysfunction

The ED1000 device offers an innovative approach to the treatment of erectile dysfunction (ED) using low-intensity shockwave therapy (LI-ESWT). This treatment method works by sending low-intensity acoustic waves to the penile region and is as follows:

  • Mechanism: The treatment aims to increase blood flow by dilating blood vessels and promoting new vessel formation.
  • Sessions Generally, a treatment process may vary between 6-12 sessions in total.
  • Effectiveness: Studies show that more than of patients have a favourable outcome from treatment.
  • Side Effects: It is a non-invasive treatment option with minimal side effects.
  • Lasting Impact: Long-term improvements have been observed with regular sessions.

Methods Used in Clinical Research

The methods used in clinical trials are important to evaluate the efficacy and safety of the ED1000 device. Trials are conducted in different patient groups and in a variety of clinical settings.

  • Randomised controlled trials (RCT): It enables the comparison of different treatment methods by randomly selecting patient groups.
  • Double-blind studies: These are studies in which both the investigators and the participants do not know which treatment they are receiving.
  • Prospective cohort studies: Evaluates the results by following a specific group of patients for a long time.
  • Retrospective analyses: It is done by re-examining the data collected in the past.
  • Meta-analyses: It combines the results of more than one study and draws a general conclusion with data from all studies.
  • Cross studies: These are studies in which the same participants are included in both treatment and control groups.

Effectiveness of the ED1000 Device

The effectiveness of the ED1000 device has been determined by clinical studies and patient evaluations.

  • Number of Studies: 12 independent studies
  • Patient Group: Nearly 800 patients

Research Findings:

  • increase in erection duration
  • improvement in sexual satisfaction
  • Rate of no side effects

Long Term Impacts:

Follow-up studies show that the effects are maintained for 12 months after treatment.

Expert Opinions:

  • Cardiologists emphasise improved sexual function as an indicator of response to treatment.
  • Urologists stated that low-intensity shock wave therapy is the first choice because it is non-invasive.

ED1000 offers a promising solution for men with erectile dysfunction.

Results Obtained in Clinical Trials

Clinical trials with the ED1000 device have shown a variety of results. Most studies have focussed on the effectiveness and safety of the device.

  • Event:
    • ED1000 has led to significant improvements in the treatment of erectile dysfunction.
    • Significant improvement was observed in of the participants.
    • Long-term effects were also found to be favourable.
  • Security:
    • No serious side effects have been reported when using the device.
    • Mild discomfort may be experienced during the treatment.
  • Patient Satisfaction:
    • Most participants were satisfied with the treatment.
    • A high satisfaction rate was recorded in user feedback.

Research shows that ED1000 is an effective and safe option for individuals experiencing erectile dysfunction.

Safety Assessment of the ED1000 Device

The safety evaluation of the ED1000 is based on several clinical studies. These evaluations include:

  1. Patient Safety:
    • No serious side effects have been reported during the use of the device.
    • Mild side effects such as minimal pain and skin irritation have been observed in the application area.
  2. Clinical Protocols:
    • The procedures were meticulously performed by specialised doctors.
    • The device was used only when necessary and under the supervision of a doctor.
  3. Long Term Effects:
    • Long-term observations show that the device is safe to use.
    • No device-induced adverse reactions were detected in routine controls.

These findings have been evaluated in the light of detailed examinations by experts and support the safety of the device.

Side Effects and Patient Tolerance

Some side effects have been observed as a result of clinical trials with the ED1000 device. These side effects and patient tolerance can be summarised as follows:

  • Slight redness of the skin: It is a temporary condition after the procedure.
  • Pain or discomfort: May be mild during and after treatment.
  • Bruising at the application site: It can be seen rarely, it usually lasts for a short time and passes spontaneously.

In terms of patient tolerance:

  1. Most patients tolerate the treatment process comfortably.
  2. Side effects are usually mild and transient.
  3. External analgesia is usually not needed.

"No serious side effects have been reported in the literature."

In the light of all these findings, it is concluded that ED1000 treatment is generally safe.

Evaluation of the Results of Clinical Trials

The data obtained as a result of clinical trials should be analysed meticulously. There are various factors to be considered in this process:

  • Measurement and Evaluation Methods: The accuracy of clinical results depends on the effectiveness of the measurement and evaluation methods used. Standard and advanced biometric analysis techniques should be preferred.
  • Patient Feedback: It is important to collect and evaluate the experiences of patients during the treatment process. This feedback plays a critical role in determining the effectiveness of treatment methods.
  • Statistical Analyses: Analysing the data obtained by statistical methods is essential for the general validity and reliability of the results. These analyses quantify the effectiveness of treatment and help to evaluate side effects.

Future of the ED1000 Device and Potential Developments

Noteworthy developments in the future of the ED1000 can be listed as follows:

  • Artificial Intelligence Integration: To make the device work smarter.
  • Portability: Develop more compact and portable versions.
  • User Friendly Interface: A simpler and more user-friendly interface design.
  • Data Analysis and Monitoring: Detailed reporting features to enable users to better monitor their treatment progress.
  • Compatibility: Provide wider device and infrastructure compatibility.
  • Economic Access: Develop cost-effective solutions to facilitate access for more patients.

These developments increase the effectiveness of the ED1000 and maximise patient satisfaction.

Patient Opinions and Experiences

Patients' experiences and feedback are very important in clinical studies and results with the ED1000 device. The following main comments and experiences were observed:

  • Improved Erection Quality: Patients have observed a marked improvement in erection quality after ED1000 treatment.
  • Increased Sexual Satisfaction: They reported that their sexual life had become more satisfying.
  • Continuity Gain: They experienced an increase in erection duration after treatment.
  • Psychological Healing: The erection problems they controlled had positive effects on their self-confidence and general psychological health.

These experiences include positive feedback in terms of overall patient satisfaction.

Comparison with Other Treatment Methods Using ED1000

When the effectiveness of the ED1000 device is compared with various other treatment methods, remarkable results emerge.

  • Medical Treatments: Phosphodiesterase type 5 inhibitors (PDE5i) are usually the first choice of treatment. However, these drugs may cause side effects and their use is limited in some patients.
  • Surgical Interventions: Methods such as penile prostheses and vascular surgery are invasive and the healing process is longer.
  • Vacuum Erectile Devices (VED): It offers an instant solution but may not give satisfactory results in the long term.
  • Psychotherapy: It is effective in erectile dysfunction due to psychological causes, but may be limited in physical causes.

The ED1000 is less invasive than these methods and has a lower side effect profile.

Conclusion and General Evaluation

Clinical trials with the ED1000 device have yielded a variety of results in different patient groups.

  • Effects on Erectile Function: The use of ED1000 was found to have a favourable effect on erectile function. A significant improvement in erection quality was observed in the majority of patients.
  • Side Effects: No serious side effects have been reported during use of the device. Mild discomforts were temporary.
  • Long Term Effects: Research shows that long-term use of the device results in lasting improvements.
  • Patient Satisfaction: Clinical trials have shown that patients are generally satisfied with the treatment process and consider treatment options again.

These results support the ED1000 device as a safe and effective treatment option.