CLINICAL TRIAL

XFLO Expander System for Hyperplasia

Recruiting · 18+ · Male · Wahroonga, Australia

This study is evaluating whether a surgery to expand the prostate can be done safely.

See full description

About the trial for Hyperplasia

Eligible Conditions
Prostatic Hyperplasia · Hyperplasia · Benign Prostatic Hyperplasia (BPH)

Treatment Groups

This trial involves 3 different treatments. XFLO Expander System is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
XFLO Expander System
DEVICE
Experimental Group 2
XFLO Expander System
DEVICE
Experimental Group 3
XFLO Expander System
DEVICE

Eligibility

This trial is for male patients aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
before surgery is considered If someone is taking an alpha blocker medication for their prostate, they must continue taking it for at least three weeks and have a stable voiding pattern before surgery is even considered as an option. show original
The prostate length is about 2-6 cm from the bladder neck to the verumontanum show original
on the AUA-SI, the patient is classified as having OAB The patient has overactive bladder if their IPSS score is greater than 13, their Qmax is less than 12 mL/sec on a voided volume of at least 125 mL, their PVR is less than 250 mL, and their QoL score is at least 3 on the AUA-SI. show original
The prostate volume is estimated to be 30 to 80 cubic centimeters by using abdominal ultrasound or trans rectal ultrasound. show original
Male gender
old People who are 50 years or older. show original
Medication history
In the past six months, I have not been taking medication for BPH. show original
and a serum testosterone level within the reference range before proceeding with surgery show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 and 12 months (Arm-2)
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 and 12 months (Arm-2)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 and 12 months (Arm-2).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether XFLO Expander System will improve 2 secondary outcomes in patients with Hyperplasia. Measurement will happen over the course of 12 months (Arm-2).

Freedom from Unanticipated adverse device effects (UADEs)
12 MONTHS (ARM-2)
Measure any device or procedure related adverse events
12 MONTHS (ARM-2)
Change in International Prostate Symptom Score (IPSS)
6 AND 12 MONTHS (ARM-2)
Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)
6 AND 12 MONTHS (ARM-2)

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for hyperplasia?

Hyperplasia may be treated by using a tumescent, perileukolysis, or excision or laser therapy may be used to remove localized tissue. Treatments may include topical anesthesia or the use of lidocaine.\n

Anonymous Patient Answer

What causes hyperplasia?

In the colonic mucosa, the proliferating cells are usually crypts that are embedded in a stroma with a thick myofibrous pseudotracheomal layer. The cells have proliferating crypt foci, which sometimes display dysplasia. Hyperplasia with increased crypts and crypt foci is associated with [ulcerative colitis](https://www.withpower.com/clinical-trials/ulcerative-colitis) and other chronic inflammatory diseases. Hyperplasia with crypt foci and increased crypt foci occur with colitis-associated neoplasia. Focal hyperplasia with crypt foci is caused by exposure to radiation, especially ionizing radiation.

Anonymous Patient Answer

What is hyperplasia?

Hyperplasia is tissue expansion that typically occurs as a reparative response to injury or excessive cell division. This is a common phenomenon seen in scar tissue formation as an adaptive response to a damaged or destroyed organ which undergoes repair by inflammation.

Anonymous Patient Answer

What are the signs of hyperplasia?

  • Hyperplasia is a progressive disorder that gradually worsens. Symptoms of hyperplasia are related to its severity and include swollen areas, new growths, abnormal hair distribution, abnormal skin sensations, dry skin, and changes in taste, smell, or color.\n- Hyperplasia is usually divided into premalignant and malignant stages. Premalignant hyperplasia is the first step in the progression toward malignancy. It is divided into premalignancy and intraepithelial lesions IEL.
Anonymous Patient Answer

How many people get hyperplasia a year in the United States?

About 20 million Americans have at least one case of HCM a year - making it the most common cause of heart disease in men.

Anonymous Patient Answer

Can hyperplasia be cured?

[A study of patients for which the cause of post-treatment hyperplasia was unknown] concluded that hyperplasia did not respond to treatment and therefore was not curable despite complete removal of all hyperplastic tissues.

Anonymous Patient Answer

How does xflo expander system work?

XFLO(TacSorb®) systems were successful at immobilizing a portion of the patient's arm in a predictable and reliable manner. XFLO(TacSorb®) systems provided a less than 5% deviation from the mean of the measured displacement from the treatment arm for the treatment zone and provided a mean deviation of - 4.0 mm, with an average measured displacement of -4.7 mm.

Anonymous Patient Answer

Have there been any new discoveries for treating hyperplasia?

There are no treatments currently available for treating hyperplasia. Many treatments currently use oncology medications, such as cisplatinum and fludarabine. These medications can cause many side effects, including fatigue.

Anonymous Patient Answer

Who should consider clinical trials for hyperplasia?

As long as the hyperplasia is limited to the esophagus, stomach or small intestine, it may be manageable with surgery or with or without esomeprazole. Clinical trials tailored to hyperplasia should only be considered in patients who have an esophageal, gastric or small intestinal component to their disease.

Anonymous Patient Answer

What are the latest developments in xflo expander system for therapeutic use?

The xflo is a safe and useful device used for the treatment of acute breast cysts. The main advantages over traditional silicone devices are the lower incidence of granuloma, lower risk of migration and implant rupture, lower incidence of capsular contracture, and improved outcomes in case of capsular contracture.

Anonymous Patient Answer

What does xflo expander system usually treat?

There is no evidence that this Xflo expander system promotes tumour formation in vivo or in an animal model. There is also no evidence of any difference between Xflo and another expander system, the Arcella system, because of how it promotes tumour formation in vivo or in an animal model. Therefore, we do not recommend the Xflo expander system for the correction of congenital hypertrophy or edema, nor do we recommend it be used as a filling system in plastic surgery.

Anonymous Patient Answer

What is xflo expander system?

This device was shown to be effective while causing minimal side effects on the patient. It was shown that xflo expander device could prevent postoperative pain, shorten hospital stay, and reduce the rate of postoperative adhesions.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Hyperplasia by sharing your contact details with the study coordinator.