Urethral StricturePhase 2NCT02948842
Clostridium Histolyticum Collagenase Injection for Urethral Disease
A Phase 2 study testing Clostridium Histolyticum Collagenase and Saline in people with Urethral Stricture, run by University of South Florida at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Clostridium Histolyticum Collagenase and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2020to 12 Apr 2023
- Phase
- Phase 2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males
- Age ≥ 18 years
- Failed prior proven conservative measures, including DVIU or balloon dilation of the stricture will be included in this study
- Able and willing to undergo regular intervention as well as evaluation as described below will be included in the study
- With a single stricture <2cm in size that can be identified on retrograde urethrogram or voiding cystourethrogram will be included in the study.
- Must agree not to participate in a clinical study involving another investigational drug or device throughout the duration of this study
- Must be competent to understand the information given in IRB approved ICF and must sign the form prior to the initiation of any study procedure
Who cannot join
- Has not yet undergone proven non-invasive measures, including DVIU or balloon dilation.
- Multiple strictures or a single stricture larger than 2cm in size, measured with retrograde urethrogram, voiding cystourethrogram, or urethral ultrasonography.
- Corporal spongiosum tissues < 5 mm in depth at proposed injection site
- Grade 5 spongiofibrosis
- Age <18
- Females
Show all 19Show fewer
- Prior urethroplasty
- Urethral fistula
- History of penile cancer, prostate cancer, or urinary tract malignancy (bladder, urethral, ureteral, or kidney).
- History of radiation (external or brachytherapy) to the pelvic organs, penis or groin.
- History of autoimmune or inflammatory bowel disease
- Contraindication to suprapubic tube placement
- Pre-procedure PVR >250mL
- Allergy or sensitivity to CHC
- Bleeding disorder or anticoagulant use other than aspirin up to 150mg/day
- Untreated urinary tract infection
- Inability to perform intermittent self-catheterization
- Participation in another clinical study or treatment with an investigational drug or device
- Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Florida - South Tampa Campus
Tampa, Florida, 33606
About this study
Official title: Clostridium Histolyticum Collagenase Injection Treatment for Urethral Disease: a Prospective, Single-center, Open-label Study
The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures.
Read the detailed description
This is an open-label, pilot study to explore the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures. Subjects will be followed for 2 years from the initial drug treatment.
- Conditions
- Urethral Stricture
- Being tested
- Clostridium Histolyticum Collagenase, Saline
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridium Histolyticum CollagenaseDrug
Also called XIAFLEX®
0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. This is based on 0.25 mL residual fluid that remains within the lumen of the injeTAK syringe. Thus, by adding the additional 0.25 mL of XIAFLEX® as a chase, we are expecting the original total of 0.08 mL of XIAFLEX® to be injected into the area of scarring.
SalineOther
Also called Injectable normal saline
0.08ml of injectable normal saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Patients will undergo instillation of local anesthesia (20 mL of 2% urethral lidocaine jelly), the patient will undergo cystoscopy, transurethral injection (via a 70 cm 4.8 Fr flexible cystoscopic needle with a 23 gauge needle tip manufactured by Laborie®, Ontario, Canada) of 0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. Receives: Drug: Clostridium Histolyticum Collagenase; Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Complication After Treatment
Number of subjects with complication after treatment with clostridium histolyticum collagenase
Measured: 84 days
Secondary outcomes (21)
Number of Patients Needing Further Intervention for Treatment of Urethral Stricture
Further intervention - defined as any medical or surgical intervention for treatment of urethral stricture.
Measured: 2 years
Number of Subjects With Recurrence of Urethral Stricture
Number of subjects with recurrence of urethral stricture
Measured: 2 years
Change From Baseline and 6 Weeks: American Urology Association Questionnaire Scores
The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms.
Measured: 6 weeks
Change From Baseline and 6 Months: American Urology Association Questionnaire Scores
The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms.
Measured: 6 months
Change From Baseline and 9 Months: American Urology Association Questionnaire Scores
The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms.
Measured: 9 months
Change From Baseline and 12 Months: American Urology Association Questionnaire Scores
The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms.
Measured: 12 months
Change From Baseline and 2 Years: American Urology Association Questionnaire Scores
The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms.
Measured: 2 years
Time to Urethral Stricture Recurrence
Measured: 2 years
Time to Additional Intervention for Urethral Stricture
Measured: 2 years
Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Uroflow)
Obstructive voiding dysfunction defined as change in uroflow
Measured: 6 weeks
Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Uroflow)
Obstructive voiding dysfunction defined as change in uroflow
Measured: 6 months
Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Uroflow)
Obstructive voiding dysfunction defined as change in uroflow
Measured: 9 months
Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Uroflow)
Obstructive voiding dysfunction defined as change in uroflow
Measured: 12 months
Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Uroflow)
Obstructive voiding dysfunction defined as change in uroflow
Measured: 18 months
Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Uroflow)
Obstructive voiding dysfunction defined as change in uroflow
Measured: 2 years
Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Post-void Residual Measurements)
Obstructive voiding dysfunction defined as change in post-void residual measurements
Measured: 6 weeks
Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)
Obstructive voiding dysfunction defined as change in post-void residual measurements
Measured: 6 months
Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)
Obstructive voiding dysfunction defined as change in post-void residual measurements
Measured: 9 months
Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)
Obstructive voiding dysfunction defined as change in post-void residual measurements
Measured: 12 months
Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)
Obstructive voiding dysfunction defined as change in post-void residual measurements
Measured: 18 months
Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Post-void Residual Measurements)
Obstructive voiding dysfunction defined as change in post-void residual measurements
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start22 May 2020
- Primary completion4 Mar 2023
- Study completion12 Apr 2023
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.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucas R Wiegand, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948842
- Sponsor's protocol ID
- CHC
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2016
- Last updated
- 3 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santucci RA, Joyce GF, Wise M. Male urethral stricture disease. J Urol. 2007 May;177(5):1667-74. doi: 10.1016/j.juro.2007.01.041.
PubMed 17437780Chenoweth CE, Saint S. Urinary tract infections. Infect Dis Clin North Am. 2011 Mar;25(1):103-15. doi: 10.1016/j.idc.2010.11.005. Epub 2010 Dec 18.
PubMed 21315996Heyns CF, Steenkamp JW, De Kock ML, Whitaker P. Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful? J Urol. 1998 Aug;160(2):356-8. doi: 10.1016/s0022-5347(01)62894-5.
PubMed 9679876Hussain M, Greenwell TJ, Shah J, Mundy A. Long-term results of a self-expanding wallstent in the treatment of urethral stricture. BJU Int. 2004 Nov;94(7):1037-9. doi: 10.1111/j.1464-410X.2004.05100.x.
PubMed 15541123Zhang K, Qi E, Zhang Y, Sa Y, Fu Q. Efficacy and safety of local steroids for urethra strictures: a systematic review and meta-analysis. J Endourol. 2014 Aug;28(8):962-8. doi: 10.1089/end.2014.0090. Epub 2014 Jun 3.
PubMed 24745607Peak TC, Mitchell GC, Yafi FA, Hellstrom WJ. Role of collagenase clostridium histolyticum in Peyronie's disease. Biologics. 2015 Sep 29;9:107-16. doi: 10.2147/BTT.S65619. eCollection 2015.
PubMed 26491251Gelbard M, Goldstein I, Hellstrom WJ, McMahon CG, Smith T, Tursi J, Jones N, Kaufman GJ, Carson CC 3rd. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. 2013 Jul;190(1):199-207. doi: 10.1016/j.juro.2013.01.087. Epub 2013 Jan 31.
PubMed 23376148Cavalcanti AG, Costa WS, Baskin LS, McAninch JA, Sampaio FJ. A morphometric analysis of bulbar urethral strictures. BJU Int. 2007 Aug;100(2):397-402. doi: 10.1111/j.1464-410X.2007.06904.x.
PubMed 17617144Sangkum P, Yafi FA, Kim H, Bouljihad M, Ranjan M, Datta A, Mandava SH, Sikka SC, Abdel-Mageed AB, Moparty K, Hellstrom WJ. Collagenase Clostridium histolyticum (Xiaflex) for the Treatment of Urethral Stricture Disease in a Rat Model of Urethral Fibrosis. Urology. 2015 Sep;86(3):647.e1-6. doi: 10.1016/j.urology.2015.06.013. Epub 2015 Jun 27.
PubMed 26126692
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clostridium Histolyticum Collagenase Injection Treatment for Urethral Disease: a Prospective, Single-center, Open-label Study
- ClinicalTrials.gov ID
- NCT02948842
- Acronym / sponsor ID
- CHC
- Conditions
- Urethral Stricture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 22 May 2020 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Posted 3 Nov 2023
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 assess the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures.
Detailed description
This is an open-label, pilot study to explore the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures. Subjects will be followed for 2 years from the initial drug treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Clostridium Histolyticum Collagenase, Other: SalinePatients will undergo instillation of local anesthesia (20 mL of 2% urethral lidocaine jelly), the patient will undergo cystoscopy, transurethral injection (via a 70 cm 4.8 Fr flexible cystoscopic needle with a 23 gauge needle tip manufactured by Laborie®, Ontario, Canada) of 0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males
- Age ≥ 18 years
- Failed prior proven conservative measures, including DVIU or balloon dilation of the stricture will be included in this study
- Able and willing to undergo regular intervention as well as evaluation as described below will be included in the study
- With a single stricture <2cm in size that can be identified on retrograde urethrogram or voiding cystourethrogram will be included in the study.
Key exclusion criteria (19 listed)
- Has not yet undergone proven non-invasive measures, including DVIU or balloon dilation.
- Multiple strictures or a single stricture larger than 2cm in size, measured with retrograde urethrogram, voiding cystourethrogram, or urethral ultrasonography.
- Corporal spongiosum tissues < 5 mm in depth at proposed injection site
- Grade 5 spongiofibrosis
- Age <18
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 |
|---|---|---|
| Clostridium Histolyticum CollagenaseAlso: XIAFLEX®0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. This is based on 0.25 mL residual fluid that remains within the lumen of the injeTAK syringe. Thus, by adding the additional 0.25 mL of XIAFLEX® as a chase, we are expecting the original total of 0.08 mL of XIAFLEX® to be injected into the area of scarring. | Drug | Treatment Group |
| SalineAlso: Injectable normal saline0.08ml of injectable normal saline | Other | Treatment Group |
Primary outcome
Number of Subjects With Complication After Treatment
Time frame: 84 days
Number of subjects with complication after treatment with clostridium histolyticum collagenase
21 secondary outcomes
Number of Patients Needing Further Intervention for Treatment of Urethral Stricture
Time frame: 2 years
Number of Subjects With Recurrence of Urethral Stricture
Time frame: 2 years
Change From Baseline and 6 Weeks: American Urology Association Questionnaire Scores
Time frame: 6 weeks
Change From Baseline and 6 Months: American Urology Association Questionnaire Scores
Time frame: 6 months
Change From Baseline and 9 Months: American Urology Association Questionnaire Scores
Time frame: 9 months
Change From Baseline and 12 Months: American Urology Association Questionnaire Scores
Time frame: 12 months
Change From Baseline and 2 Years: American Urology Association Questionnaire Scores
Time frame: 2 years
Time to Urethral Stricture Recurrence
Time frame: 2 years
Time to Additional Intervention for Urethral Stricture
Time frame: 2 years
Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Uroflow)
Time frame: 6 weeks
Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Uroflow)
Time frame: 6 months
Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Uroflow)
Time frame: 9 months
Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Uroflow)
Time frame: 12 months
Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Uroflow)
Time frame: 18 months
Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Uroflow)
Time frame: 2 years
Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Post-void Residual Measurements)
Time frame: 6 weeks
Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)
Time frame: 6 months
Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)
Time frame: 9 months
Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)
Time frame: 12 months
Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements)
Time frame: 18 months
Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Post-void Residual Measurements)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17437780Santucci RA, Joyce GF, Wise M. Male urethral stricture disease. J Urol. 2007 May;177(5):1667-74. doi: 10.1016/j.juro.2007.01.041.
- Results publication: PubMed 21315996Chenoweth CE, Saint S. Urinary tract infections. Infect Dis Clin North Am. 2011 Mar;25(1):103-15. doi: 10.1016/j.idc.2010.11.005. Epub 2010 Dec 18.
- Results publication: PubMed 9679876Heyns CF, Steenkamp JW, De Kock ML, Whitaker P. Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful? J Urol. 1998 Aug;160(2):356-8. doi: 10.1016/s0022-5347(01)62894-5.
- Results publication: PubMed 15541123Hussain M, Greenwell TJ, Shah J, Mundy A. Long-term results of a self-expanding wallstent in the treatment of urethral stricture. BJU Int. 2004 Nov;94(7):1037-9. doi: 10.1111/j.1464-410X.2004.05100.x.
- Results publication: PubMed 24745607Zhang K, Qi E, Zhang Y, Sa Y, Fu Q. Efficacy and safety of local steroids for urethra strictures: a systematic review and meta-analysis. J Endourol. 2014 Aug;28(8):962-8. doi: 10.1089/end.2014.0090. Epub 2014 Jun 3.
- Results publication: PubMed 26491251Peak TC, Mitchell GC, Yafi FA, Hellstrom WJ. Role of collagenase clostridium histolyticum in Peyronie's disease. Biologics. 2015 Sep 29;9:107-16. doi: 10.2147/BTT.S65619. eCollection 2015.
- Results publication: PubMed 23376148Gelbard M, Goldstein I, Hellstrom WJ, McMahon CG, Smith T, Tursi J, Jones N, Kaufman GJ, Carson CC 3rd. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. 2013 Jul;190(1):199-207. doi: 10.1016/j.juro.2013.01.087. Epub 2013 Jan 31.
- Results publication: PubMed 17617144Cavalcanti AG, Costa WS, Baskin LS, McAninch JA, Sampaio FJ. A morphometric analysis of bulbar urethral strictures. BJU Int. 2007 Aug;100(2):397-402. doi: 10.1111/j.1464-410X.2007.06904.x.
- Results publication: PubMed 26126692Sangkum P, Yafi FA, Kim H, Bouljihad M, Ranjan M, Datta A, Mandava SH, Sikka SC, Abdel-Mageed AB, Moparty K, Hellstrom WJ. Collagenase Clostridium histolyticum (Xiaflex) for the Treatment of Urethral Stricture Disease in a Rat Model of Urethral Fibrosis. Urology. 2015 Sep;86(3):647.e1-6. doi: 10.1016/j.urology.2015.06.013. Epub 2015 Jun 27.
- Individual participant dataSharing planned: No
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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.
Lucas R Wiegand, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clostridium Histolyticum Collagenase and Saline in people with Urethral Stricture, run by University of South Florida at 1 site in United States.
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 7 inclusion and 19 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 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2023). 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?
Number of Subjects With Complication After Treatment (time frame: 84 days). 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 NCT02948842, which also lists 9 linked publications.
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 3 Nov 2023.