Urinary Incontinence, StressAMS051NCT00904969

A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence

A study testing The AMS Male Transobturator Sling System and AdVance Male Sling in people with Urinary Incontinence, Stress, run by American Medical Systems at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication. Read more about this study

Who is it for?: Ages 40 years and older, men only
Conditions the study is for: Urinary Incontinence, Stress
What is being tested?: The AMS Male Transobturator Sling System and AdVance Male Sling
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 11 sitesin 2 countries
Study dates: Sep 2005to Nov 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject has agreed to be implanted with the AMS Male Transobturator Sling System.
The subject is willing and able to give valid informed consent.
The subject is > 40 years of age.
The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management.
The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day.
Internal sphincter contractility confirmed by endoscopic view.

Show all 10Show fewer

The subject's primary etiology is TUR, TURP, radical prostatectomy, open prostatectomy, or suprapubic prostatectomy
Pre-existing urological conditions, other than incontinence have been treated and are under control.
The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
The subject is a good surgical candidate.

Who cannot join

The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
The subject has an atonic bladder.
The subject has a post-void residual > 75 cc.
The subject has detrusor-external sphincter dyssynergia.
The subject has a urinary tract infection (UTI).
The subject was treated with pelvic radiation within the last 6 months.

Show all 15Show fewer

The subject currently has an inflatable penile prosthesis.
The subject self-catheterizes.
The subject has symptomatic or unstable bladder neck stricture disease.
The subject has a history of urethral strictures that may require repetitive instrumentation.
The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents).
The subject has a history of connective tissue or autoimmune conditions.
The subject has a compromised immune system.
The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

United States10 sites

The University of Michigan HS
Ann Arbor, Michigan, 48109
CHCS - Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Colorado Health
Denver, Colorado, 80262
Baylor College of Medicine
Houston, Texas, 77030
Century City Docotrs Hospital
Los Angeles, California, 90067
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Centennial Hospital
Nashville, Tennessee, 37203
Norfolk General
Norfolk, Virginia, 23502
Christus Santa Rosa Hospital
San Antonio, Texas, 78229

Other trials in United States

Canada1 site

Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: A Pre-Market Study of the AMS Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence

The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication.

Read the detailed description

A multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionnaire). Intra-operative procedural data will be collected.

Pad weight and incontinence severity rating (using the International Consultation on Incontinence Questionnaire (ICIQ)) will be used to characterize continence status.

Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.

Conditions: Urinary Incontinence, Stress
Being tested: The AMS Male Transobturator Sling System, AdVance Male Sling
Keywords: Urinary Incontinence, Stress, Intrinsic sphincter deficiency, Secondary, Transurethral Resection (TUR), Transurethral Resection of the Prostate (TURP), Radical prostatectomy, Open prostatectomy, Post-suprapubic prostatectomy
Medical subject headings: Urinary Incontinence, Stress, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The AMS Male Transobturator Sling SystemDevice
The AMS Male Transobturator Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD) secondary to radical prostatectomy. The Male Transobturator Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.
AdVance Male SlingDevice
Also called Male TO, transobturator sling, suburethral sling, retrourethral sling
A transobturator sling for the treatment of post-prostatectomy incontinence

Study groups in NCT00904969
Study group	Role	What they receive
AMS Transobturator Male Sling System	Experimental	Not described Receives: Device: The AMS Male Transobturator Sling System; Device: AdVance Male Sling

What is being measured

The primary outcome is the main question the study is designed to answer.

Procedural Endpoint: Procedure Time From First Incision to Closing.
Characterize procedure time from first incision to closing.
Measured: During Procedure, Approximately 60 Minutes
Procedural Endpoint: Type of Anesthesia Used
Describe the type of anesthesia used.
Measured: During Procedure, Approximately 60 Minutes
Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative
Number of participants requiring the use of a foley catheter intra-operatively.
Measured: During Procedure, Approximately 60 Minutes
Procedural Endpoint: Rate of Foley Catheter Use - Post-operative
Number of participants requiring the use of a foley catheter who were able to void prior to discharge.
Measured: post-operative to discharge
Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge
Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.
Measured: post discharge
Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures
Characterize procedural parameters including the use of tack sutures.
Measured: During Procedure, Approximately 60 Minutes
Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection
Characterize procedural parameters, including muscle dissection across all participants.
Measured: During Procedure, Approximately 60 Minutes
Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning
Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.
Measured: During Procedure, Approximately 60 Minutes
Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively
Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.
Measured: During Procedure, Approximately 60 Minutes

Secondary outcomes (10)

Subject Satisfaction Endpoint: 1-Hour Pad Weight
Summarize subject satisfaction of 1-hour pad weight for participants.
Measured: Baseline to 24 month
Subject Satisfaction Endpoint: 24-Hour Pad Weight
Summarize subject satisfaction with 24-hour pad weight across participants.
Measured: Baseline to 24 month
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)
Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used).
Measured: Baseline to 24 month
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)
Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used).
Measured: Baseline to 24 Month
Subject Satisfaction Endpoint: Pads Per Day Use
Summarize the subject satisfaction using pads per day use collected in follow-up in participants.
Measured: Baseline to 24 Months
Subject Satisfaction Endpoint: Quality of Life I-QOL Scores
The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence. A possible total score can be 0-100, with a higher score meaning less problems.
Measured: Baseline to 24 Months
Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores
The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence. A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed. Scores may range from 0 to 21. Improvement in the subject's quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score.
Measured: Baseline to 24 Months
Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores
Improvement in the subject's quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score. Scores may range from 0 to 100.
Measured: Baseline to 24 Months
Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status
Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations
Measured: 6 Weeks post implant to 24 Months
Procedural and Device Complication Rates
Percentage of participants with serious and non-serious adverse events.
Measured: Procedure to 24 Months Post implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Nov 2009

First posted20 May 2009 (estimated)
Study startSep 2005
Primary completionMay 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00904969
Sponsor's protocol ID: AMS051
Acronym: AMS051
Status last verified: Jan 2017
First submitted: 18 May 2009
Last updated: 30 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Data generated from this study may be used to support clinical publications, internal device documents for marketing and/or instructional manuals, etc.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy

All Urinary Incontinence, Stress trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pre-Market Study of the AMS Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
ClinicalTrials.gov ID: NCT00904969
Acronym / sponsor ID: AMS051 / AMS051
Conditions: Urinary Incontinence, Stress
Keywords: Urinary Incontinence, Stress, Intrinsic sphincter deficiency, Secondary, Transurethral Resection (TUR), Transurethral Resection of the Prostate (TURP), Radical prostatectomy, Open prostatectomy, Post-suprapubic prostatectomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: American Medical SystemsIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: May 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 20 May 2009 (estimated)
Results: Posted 30 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication.

Detailed description

Pad weight and incontinence severity rating (using the International Consultation on Incontinence Questionnaire (ICIQ)) will be used to characterize continence status.

Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AMS Transobturator Male Sling System	Experimental	Device: The AMS Male Transobturator Sling System, Device: AdVance Male Sling

Who may qualify

Ages: 40 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

The subject has agreed to be implanted with the AMS Male Transobturator Sling System.
The subject is willing and able to give valid informed consent.
The subject is > 40 years of age.
The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management.
The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day.

Key exclusion criteria (15 listed)

The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
The subject has an atonic bladder.
The subject has a post-void residual > 75 cc.
The subject has detrusor-external sphincter dyssynergia.
The subject has a urinary tract infection (UTI).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The AMS Male Transobturator Sling SystemThe AMS Male Transobturator Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD) secondary to radical prostatectomy. The Male Transobturator Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.	Device	AMS Transobturator Male Sling System
AdVance Male SlingAlso: Male TO, transobturator sling, suburethral sling, retrourethral slingA transobturator sling for the treatment of post-prostatectomy incontinence	Device	AMS Transobturator Male Sling System

Primary outcome

Procedural Endpoint: Procedure Time From First Incision to Closing.
Time frame: During Procedure, Approximately 60 Minutes
Characterize procedure time from first incision to closing.
Procedural Endpoint: Type of Anesthesia Used
Time frame: During Procedure, Approximately 60 Minutes
Describe the type of anesthesia used.
Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative
Time frame: During Procedure, Approximately 60 Minutes
Number of participants requiring the use of a foley catheter intra-operatively.
Procedural Endpoint: Rate of Foley Catheter Use - Post-operative
Time frame: post-operative to discharge
Number of participants requiring the use of a foley catheter who were able to void prior to discharge.
Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge
Time frame: post discharge
Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.
Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures
Time frame: During Procedure, Approximately 60 Minutes
Characterize procedural parameters including the use of tack sutures.
Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection
Time frame: During Procedure, Approximately 60 Minutes
Characterize procedural parameters, including muscle dissection across all participants.
Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning
Time frame: During Procedure, Approximately 60 Minutes
Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.
Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively
Time frame: During Procedure, Approximately 60 Minutes
Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.

10 secondary outcomes

Subject Satisfaction Endpoint: 1-Hour Pad Weight
Time frame: Baseline to 24 month
Subject Satisfaction Endpoint: 24-Hour Pad Weight
Time frame: Baseline to 24 month
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)
Time frame: Baseline to 24 month
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)
Time frame: Baseline to 24 Month
Subject Satisfaction Endpoint: Pads Per Day Use
Time frame: Baseline to 24 Months
Subject Satisfaction Endpoint: Quality of Life I-QOL Scores
Time frame: Baseline to 24 Months
Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores
Time frame: Baseline to 24 Months
Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores
Time frame: Baseline to 24 Months
Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status
Time frame: 6 Weeks post implant to 24 Months
Procedural and Device Complication Rates
Time frame: Procedure to 24 Months Post implant

Results and safety

Results posted to the registry on 30 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treated Participants	50	31

Primary outcome: Procedural Endpoint: Procedure Time From First Incision to Closing.

Time frame: During Procedure, Approximately 60 Minutes. Mean (Standard Deviation). Unit: minutes

Measure	Treated Participants n = 50
Value	61.8 (25.4)

Primary outcome: Procedural Endpoint: Type of Anesthesia Used

Time frame: During Procedure, Approximately 60 Minutes. Count of participants. Unit: Participants

Measure	Treated Participants n = 50
General	41
Spinal	9

Primary outcome: Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative

Time frame: During Procedure, Approximately 60 Minutes. Count of participants. Unit: Participants

Measure	Treated Participants n = 50
Value	44

Primary outcome: Procedural Endpoint: Rate of Foley Catheter Use - Post-operative

Time frame: post-operative to discharge. Count of participants. Unit: Participants

Measure	Treated Participants n = 50
Value	39

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected at the implant, 6 weeks, 3 month, 6 month, 12 month, and 24 month visits.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treated Participants	2 of 50 (4%)	25 of 50 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Data generated from this study may be used to support clinical publications, internal device documents for marketing and/or instructional manuals, etc.

Related trials for Urinary Incontinence, Stress

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gregory Bales, M.D. principal investigator

University of Chicago Hospital

Timothy Boone, M.D. principal investigator

Baylor College of Medicine

Karyn Eilber, M.D. principal investigator

Century City Doctors Hospital

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The AMS Male Transobturator Sling System and AdVance Male Sling in people with Urinary Incontinence, Stress, run by American Medical Systems at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural Endpoint: Procedure Time From First Incision to Closing. (time frame: During Procedure, Approximately 60 Minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00904969.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.