XFLO Expander System for Enlarged Prostate

(EXPANDER-1 Trial)

Not currently recruiting at 5 trial locations

Overseen By Joyce T. Su, MPH

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: MedeonBio, Inc.

Must be taking: 5-alpha-reductase inhibitors, Alpha-blockers

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Previous BPH procedure, UTI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1, 6, or 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device called the XFLO Expander System to determine if it can safely and effectively help men with symptoms from an enlarged prostate. The focus is on easing lower urinary tract symptoms, such as frequent urination or difficulty starting to urinate, caused by benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate. Participants will have the device implanted for varying durations—1, 6, or 12 months—to assess its effectiveness. Suitable candidates have experienced symptoms related to BPH and have not undergone prostate surgery or have certain other conditions. As an unphased trial, this study offers patients the chance to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

If you are on BPH-related medications, you must have been on 5-alpha-reductase inhibitors for at least 3 months or alpha-blockers for at least 3 weeks with a stable voiding pattern. The protocol does not specify about other medications, but you should discuss your current medications with the trial team.

What prior data suggests that the XFLO Expander System is safe for treating lower urinary tract symptoms?

Research shows that the XFLO Expander System, also known as the Mercury Expander System, is being tested for its safety in treating urinary problems caused by an enlarged prostate. Studies indicate that this device is generally well-tolerated. Early results from a study called EXPANDER-1 found that the procedure is safe and minimally invasive, requiring no large cuts. Importantly, it might also help avoid the need for a catheter, a tube used to drain urine from the bladder, after the procedure.

Overall, these findings suggest that the XFLO Expander System could be a safe option for those with urinary issues from an enlarged prostate. However, as with any medical treatment, individual experiences may vary, and discussing options with healthcare providers is always recommended. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the XFLO Expander System for enlarged prostate because it offers a novel, less invasive approach compared to traditional treatments like medication, surgery, or catheterization. Unlike these methods, the XFLO Expander System is a device implanted temporarily to relieve urinary symptoms by physically expanding the prostate, potentially reducing discomfort and recovery time associated with surgery. Additionally, the trial explores different implantation durations—1, 6, and 12 months—providing valuable insights into the optimal treatment length for effectiveness and patient comfort. This could lead to a more personalized treatment strategy, enhancing quality of life for patients with enlarged prostates.

What evidence suggests that the XFLO Expander System is effective for treating enlarged prostate?

Research shows that the XFLO Expander System holds promise for men experiencing difficulty urinating due to an enlarged prostate. One study demonstrated that the device provided quick relief, with a 40% improvement in symptoms just two weeks after implantation. In this trial, participants will be assigned to different arms, with the XFLO device implanted for varying durations: 1 month, 6 months, or 12 months. Patients who used the XFLO device for up to six months reported a significant drop in their symptom scores, which measure symptom severity. These early results suggest the device could be a helpful option for managing symptoms of an enlarged prostate. ^{1 3 5 6 7}

Who Is on the Research Team?

Henry Woo, MD

Principal Investigator

Australian Clinical Trials Pty Ltd

Are You a Good Fit for This Trial?

Men over 50 with benign prostatic hyperplasia (BPH) causing urinary issues, who haven't taken BPH meds in the last 6 months or have a stable pattern on current meds. They should have a prostate size of 30-80 cc and meet specific criteria for urinary flow and symptoms. Excluded are those with other health conditions that could affect results, previous BPH procedures, certain medication use, or allergies to nickel.

Inclusion Criteria

I haven't taken medication for an enlarged prostate in the last 6 months.

I am 50 years old or older.

Prostatic urethra length of 2.0-6.0 cm, as measured from bladder neck to verumontanum, using cystoscopy (or prostate length from bladder neck to external sphincter of 2.0-8.0 cm during screening visit, using ultrasound)

Exclusion Criteria

I expect to need more surgery or treatment for other health issues during the study.

I currently have, or recently had, a urinary tract infection.

Life expectancy of less than 24 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the XFLO Expander System implantation for 1, 6, or 12 months, depending on the assigned arm

1, 6, or 12 months

Follow-up

Participants are monitored for safety and effectiveness after device retrieval

6 months

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness, including assessment of adverse device effects

12 months

What Are the Treatments Tested in This Trial?

Interventions

• XFLO Expander System (Mercury)

Trial Overview The trial is testing the XFLO Expander System's safety and ability to treat lower urinary tract symptoms due to BPH. Participants will undergo a procedure using this system to see if it improves their symptoms without causing significant complications.

How Is the Trial Designed?

Group I: Arm-3: Device implantation for 12 months Experimental Treatment 1 Intervention

Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved.

Group II: Arm-2: Device implantation for 6 months Experimental Treatment 1 Intervention

Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved.

Group III: Arm-1: Device implantation for 1 month Experimental Treatment 1 Intervention

Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.

Who Is Running the Clinical Trial?

MedeonBio, Inc.

Lead Sponsor

Trials

1

Recruited

50+

Citations

1. prodeonmedical.com prodeonmedical.com/interim-results-of-the-expander-1-clinical-study/

Interim results of the EXPANDER-1 Clinical Study In addition, the XFLO Expander System was demonstrated to be effective at providing immediate symptom relief (2 weeks post-implant) with 40% ...

2. withpower.com withpower.com/trial/phase-prostatic-hyperplasia-10-2018-d3a61

XFLO Expander System for Enlarged Prostate · Info ... This trial is testing a new device called the Mercury Expander system, which aims to help men who have trouble urinating because of an enlarged prostate.

3. urologytimes.com urologytimes.com/view/novel-minimally-invasive-bph-device-shows-early-promise

Novel minimally-invasive BPH device shows early promise Among patients with a dwell time of up to 6 months, there was a 40% reduction in International Prostate Symptom Score. Efficacy of XFLO was ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8543673/

Minimally invasive treatments for lower urinary tract symptoms ... Newer devices, such as the XFLO Expander system, have been tested in pilot studies, with promising results (Woo 2020). Transurethral microwave thermotherapy.

5. clinconnect.io clinconnect.io/trials/NCT03758222

Safety and Feasibility of the XFLO Expander System This clinical trial is studying a new treatment method called the Mercury Expander System for men who have urinary problems caused by an enlarged prostate, a ...

6. clinicaltrial.be clinicaltrial.be/en/details/6229?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Safety and Feasibility of the XFLO Expander System (Mercu... A prospective, non-randomized, two-arm, multi-center clinical trial designed to evaluate the safety and feasibility of the Mercury Expander ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35641601/

introduction of the novel Urocross™ Expander System for ... Conclusions: Preliminary results demonstrate that the Urocross Expander System is a feasible and safe procedure for treating BPH/LUTS. A strong ...