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Memokath 028SW Urethral Stent

Phase 1

Prostate Cancer | Unknown | Oncology |Community Health Systems, Inc.|Last Updated: Dec 21, 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Memokath 028SW Urethral Stent · 1 trial · 2 indications

Phase 1 1
NCT00252941Prophylactic Urethral Stenting With Memokath After Prostate Implantation for Prostate AdenocarcinomaProstate Cancer
COMPLETED20 Analytics
PHASE1COMPLETED
Prophylactic Urethral Stenting With Memokath After Prostate Implantation for Prostate Adenocarcinoma
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Morbidities assessed on RTOG Morbidity Scale weekly for 12 weeks after PI then biweekly for next 12 weeks
Clinic visits at 2 weeks, 3 months and 6 months; physical exam to include urine flow rate, post-void residual and urinalysis
CT at 1 month post-brachytherapy
Device removal at 6 months (earlier if adverse event or patient wishes to discontinue trial)
Cystoscopy to assess urethra after stent removal

Secondary Endpoints

AUA score to assess severity of urinary symptoms
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Memokath 028SW Urethral StentDEVICE -
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Eligibility Criteria

Age Range50 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * eligible for prostate seed implant * 50 years of age or older * able to give informed consent Exclusion Criteria: * presence of any other urologic implant, including stents,penile prosthesis or artificial sphincter * history of transurethral resection of prostate (TURP)proce...

Countries:United States
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about Memokath 028SW Urethral Stent

What is Memokath 028SW Urethral Stent used for in prostate cancer?

Memokath 028SW Urethral Stent is used to prevent bladder outlet obstruction after prostate implantation for prostate adenocarcinoma. It is placed prophylactically in patients undergoing brachytherapy for prostate cancer to maintain urethral patency and reduce post-procedure urinary complications.

Who is developing Memokath 028SW Urethral Stent?

Memokath 028SW Urethral Stent is being developed by Community Health Systems, Inc. (NYSE: CYH). The company is conducting clinical research on this device for use in prostate cancer patients.

What phase is Memokath 028SW Urethral Stent in?

Memokath 028SW Urethral Stent is in Phase 1 clinical development. It is an investigational device, not yet approved for commercial use. One Phase 1 trial has been completed to evaluate its safety and feasibility in the intended patient population.

What clinical trials has Memokath 028SW Urethral Stent been in?

Memokath 028SW Urethral Stent has been studied in one completed clinical trial, NCT00252941. This Phase 1 trial enrolled 20 male patients aged 50 years and older with prostate cancer and post-brachytherapy bladder outlet obstruction. The trial was conducted in the United States.

Is Memokath 028SW Urethral Stent FDA approved?

Memokath 028SW Urethral Stent is not FDA approved. It is an investigational device currently in Phase 1 clinical development. The completed trial was uncontrolled and not randomized, and the device has not yet received regulatory approval for marketing.