Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000760279
Ethics application status
Approved
Date submitted
18/08/2009
Date registered
2/09/2009
Date last updated
2/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and Feasibility of a Transurethral Endoscopic Procedure for the Luminal Restoration of the Prostatic Urethra: A Preliminary Investigation
Scientific title
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia (BPH) 237019 0
Condition category
Condition code
Renal and Urogenital 239844 239844 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The NeoTract Anchor System is a mechanical device that is designed to hold back the lobes of the prostate and relieve symptoms associated with urinary obstruction. The device is delivered transurethrally under endoscopic guidance.

The procedure duration is usually 90 minutes or less. Once implanted, the device remains permanently in place.
Intervention code [1] 236762 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238163 0
The aim of this study is to determine whether the transurethral placement of the NeoTract Anchor is feasible. This will be determined by the successful delivery of one or more devices and procedure completion. Successful device delivery can be visually confirmed via real-time camera images.
Timepoint [1] 238163 0
Intra-operative
Primary outcome [2] 238164 0
The aim of this study is to determine whether the placement of the NeoTract anchor is safe, as determined by the absence of any serious adverse events reported either by the patient or observed by the investigator, relating to the procedure or to the anchoring devices themselves, either during the operation or in the follow-up period.
Timepoint [2] 238164 0
Intra-operative, 24 hours after procedure, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and annually thereafter for the 7 year duration.
Secondary outcome [1] 242445 0
Patient reported outcome - comparing the baseline and patient completed International Prostate Symptom Score (IPSS) questionnaire to be completed by the participant.
Timepoint [1] 242445 0
Baseline, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and annually thereafter for the 7 year duration.
Secondary outcome [2] 257266 0
Patient reported outcome - comparing the baseline Benign Prostatic Hypertrophy Impact Index (BPHII score) questionnaire to be completed by the participant.
Timepoint [2] 257266 0
Baseline, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and annually thereafter for the 7 year duration.
Secondary outcome [3] 257267 0
Patient reported outcome - comparing the baseline Quality of Life (QoL) question to be completed by the participant.
Timepoint [3] 257267 0
Baseline, 2 weeks, 4 week, 6 weeks, 3 months, 6 months, 1 year and annually thereafter for the 7 year duration.
Secondary outcome [4] 257268 0
Measuring free urine flow. Assessment is performed using a special collection toilet.
Timepoint [4] 257268 0
Baseline, 24-48 hours post procedure, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and annually thereafter for the 7 year duration.
Secondary outcome [5] 257269 0
Measuring residual urine volume. Assessment is performed using bladder ultrasound.
Timepoint [5] 257269 0
Baseline, 24-48 hours post procedure, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and annually thereafter for the 7 year duration.

Eligibility
Key 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
grams

- 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
pre-treatment transrectal ultrasound and
prostate tissue biopsy, if clinically
indicated. Biopsy not required if
performed within 6 months of treatment
date.
-
Minimum age
55 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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
that may confound results of study, or
pose additional riskto subject.

- Patient with a life expectancy of less than
2 years

- Previous prostate surgery, dilation, stent,
laser, hyperthermia (ie non-
pharmaceutical prostate treatment).

- PSA > 10 ng/ml.

- Known, or suspected urological conditions
which may effect voiding function such
as confirmed or suspected malignancy
of the bladder or prostate, previous
pelvic irradiation or radical pelvic
surgery, neurogenic bladder and/or
sphincter abnormalities, cystolithiasis
or haematuria within 3 months,
urinarytract infection, urethral
strictures, bladder neck contracture,
active clinical prostatitis, bladder
pathologies or diabetes mellitus
affecting bladder function.

- Compromised renal function (serum
creatinine > 1.58 mg/l or > 0.1 mmol/L)
(ref: medcalc version 5.3 palm/os)
(medcalc.med-ia.net)

- Previous rectal surgery, other than
hemorrhoidectomy, that may have
distorted the pelvic anatomy, or any
implants in the pelvic/femoral
region.

- Subject interested in future fertility.

- Concomitant medications: beta-blockers,
antihistaminics, anticonvulsants, and
antispasmodics within 1 week of
treatment unless there is documented
evidence that the subject has been on
the same drug dose for at least 6
months with a stable voiding pattern
(the drug dose should not be altered or
discontinued for entrance into or
throughout the study).

- Anti-coagulant medication other than
acetylsalicylic acid (ASA) (aspirin) or
clopidogrel. ASA and clopidogrel must be
ceased 7 days prior to the procedure.

- 5-alpha-reductase inhibitors within 6
months of pre treatment evaluation
unless there is documented evidence
that the subject has been on the same
drug dose for at least 6 months with a
stable voiding pattern (The drug dose
should not be altered or discontinued
for entrance into or thourghout the
study).

- Antidepressants, anticholinergics, or
alpha-blockers within 1 week of the
pretreatment evaluation.

- Anti-androgens or gonadotropin-releasing
hormone (GnRH) analogs within 2
months of pretreatment evaluation.

- Any abnormal coagulopathy.

- Evidence of current urinary tract infection
(UTI)

- Evidence of current infectious process.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237306 0
Commercial sector/Industry
Name [1] 237306 0
NeoTract, Inc.
Country [1] 237306 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
NeoTract, Inc.
Address
4473 Willow Road, Suite 100
Pleasanton, CA 94588
Country
United States of America
Secondary sponsor category [1] 236791 0
Commercial sector/Industry
Name [1] 236791 0
Five Corners Pty Ltd
Address [1] 236791 0
13/76 Reserve Road
Artarmon, NSW 2064
Country [1] 236791 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239406 0
UOW & SESIAHS (University of Wollongong & South Eastern Sydney & Illawarra Area Health Services)
Ethics committee address [1] 239406 0
Research Services Officer

University of Wollongong

Northfields Ave

Wollongong NSW 2522

site for Figtree Private Hospital
Ethics committee country [1] 239406 0
Australia
Date submitted for ethics approval [1] 239406 0
Approval date [1] 239406 0
12/11/2005
Ethics approval number [1] 239406 0
CT05/027
Ethics committee name [2] 239412 0
Austin Hospital Human Research Ethics Committee (HREC)
Ethics committee address [2] 239412 0
Research Ethics Unit

PO Box 5555

Heidelberg VIC 3084

site for Austin Hospital & Heidelberg Repatriation Hospital
Ethics committee country [2] 239412 0
Australia
Date submitted for ethics approval [2] 239412 0
Approval date [2] 239412 0
13/05/2009
Ethics approval number [2] 239412 0
108/2005
Ethics committee name [3] 239413 0
South Metropolitan Area Healsth Service
Ethics committee address [3] 239413 0
Royal Perth Hospital

Room 4112 Level 4

Kirkman House

50 Murray Street

Perth W.A. 3008

site for Royal Perth Hospital
Ethics committee country [3] 239413 0
Australia
Date submitted for ethics approval [3] 239413 0
Approval date [3] 239413 0
07/01/2009
Ethics approval number [3] 239413 0
EC 2009/040
Ethics committee name [4] 239414 0
St John of God Healthcare Ethics Committee
Ethics committee address [4] 239414 0
Level 4, St John of God House
177 Cambridge Street
SUBUACO W.A. 3008

site for St John of God Hospital
Ethics committee country [4] 239414 0
Australia
Date submitted for ethics approval [4] 239414 0
23/04/2009
Approval date [4] 239414 0
Ethics approval number [4] 239414 0
365
Ethics committee name [5] 239415 0
North Coast Area Health Service HREC
Ethics committee address [5] 239415 0
PO Box 126

Port Macquarie NSW 2444

site for Port Macquarie Private Hospital
Ethics committee country [5] 239415 0
Australia
Date submitted for ethics approval [5] 239415 0
Approval date [5] 239415 0
14/05/2009
Ethics approval number [5] 239415 0
HREC 464C
Ethics committee name [6] 239416 0
Sydney West Area Health Service
Ethics committee address [6] 239416 0
Westmead Hospital Campus

Cnr Hawkesbury and Darcy Roads

Westmead NSW 2145

site for Westmead Hospital
Ethics committee country [6] 239416 0
Australia
Date submitted for ethics approval [6] 239416 0
Approval date [6] 239416 0
12/11/2005
Ethics approval number [6] 239416 0
HREC2005/10/4.18 (2199)

Summary
Brief summary
Luminal restoration of the prostatic urethra involves implanting the NeoTract Anchor System, which is designed to hold back the lobes of the prostate, and open the urethra (the tube that carries urine from your bladder to the outside of your body) to relieve symptoms associated with urinary obstruction.

This study is a prospective, open-label feasibility study enrolling up to 70 participants. Safety and feasibility are the primary endpoints while patient questionnaires and therapeutic effectiveness is assessed as a secondary endpoint. Follow-up visits are at 24 hours, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year, and annually thereafter for the 7 year duration
Trial website
NA
Trial related presentations / publications
American Urological Association (AUA) 2009
"The Prostatic Urethral Lift: A Novel Minimally Invasive Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia"
Public notes

Contacts
Principal investigator
Name 29745 0
Address 29745 0
Country 29745 0
Phone 29745 0
Fax 29745 0
Email 29745 0
Contact person for public queries
Name 12992 0
Tamara Vayson
Address 12992 0
NeoTract, Inc.
4473 Willow Road, Suite 100
Pleasanton, CA 94588
Country 12992 0
United States of America
Phone 12992 0
+1 925 -401-0700
Fax 12992 0
+1 925-401-0699
Email 12992 0
info@neotract.com
Contact person for scientific queries
Name 3920 0
Tamara Vayson
Address 3920 0
4473 Willow Road, Suite 100
Pleasanton, CA 94588
Country 3920 0
United States of America
Phone 3920 0
+1 925-401-0700
Fax 3920 0
+1 925-401-0699
Email 3920 0
info@neotract.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.