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Clinical Trials/ACTRN12609000760279
ACTRN12609000760279
Recruiting
未知

Safety and Feasibility of a Transurethral Endoscopic Procedure for the Luminal Restoration of the Prostatic Urethra in males with benign prostatic hyperplasia: A Preliminary Investigation

eoTract, Inc.0 sites70 target enrollmentSeptember 2, 2009
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ConditionsBenign Prostatic Hyperplasia (BPH)Renal and Urogenital - Other renal and urogenital disorders

Overview

Phase
未知
Intervention
Not specified
Conditions
Benign Prostatic Hyperplasia (BPH)
Sponsor
eoTract, Inc.
Enrollment
70
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 2, 2009
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
eoTract, Inc.

Eligibility Criteria

Inclusion Criteria

  • •Diagnosis of lateral lobe symptomatic BPH
  • •\- IPSS Symptom score \>13
  • •\- Peak urine flow rate\> than 5ml/sec but
  • •\<12ml/sec on a voided volume \> 125 ml
  • •\- Prostate volume \>20 grams to \<100
  • •\- American Society of Anesthesiologists
  • •(ASA) risk group class I\-III
  • •\- Normal microscopic urinalysis
  • •\- Stable prostate\-specific antigen (PSA)
  • •over two years, or agrees to undergo a

Exclusion Criteria

  • •\- Mental capacity, dementia or inability to
  • •give informed consent.
  • •\- Subject in retention, or with a previous
  • •history of urinary retention.
  • •\- Post void residual volume \>250 ml by
  • •Ultrasound.
  • •\- Prostate gland with obstructive median
  • •lobe or prominent bladder neck requiring
  • •intervention.
  • •\- History of illness/symptoms or surgery

Outcomes

Primary Outcomes

Not specified

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