Urinary RetentionBlueHaloCoilNCT05714488
Evaluation of the "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction
A study testing blue halo coil catheter in people with Urinary Retention, run by Blue Halo Biomedical, LLC at 4 sites in United States.
Trial summary
The Investigators will study a device for men in urinary retention secondary to Benign Prostatic Hyperplasia, BPH ,who are catheter dependent or who have a Post Void Residual > 350cc. The hypothesis is that the device will allow these participants to return to volitional voiding with a Post Void Residual <75 cc. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention
- What is being tested?
- blue halo coil catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Aug 2022to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subjects > 50 years of age
- Able to provide consent
- Participants in urinary retention with post void residual > 350 cc
- Urinary retention is due to BPH with a prostate volume > 50cc or a prostatic urethral length of 5+ cm
- Subjects with a PSA > 4 ng/ml and a PSA density of 0.1 or less
- Subjects on alpha- blocking drugs or 5-alpha-reductase inhibitor drugs may be included
Who cannot join
- Inability to undergo bladder catheterization ( i.e. urethral stricture)
- Presence of gross hematuria
- Lack of cognitive ability to give consent or keep appointments
- History of Prostate Cancer
- Subject with a PSA > 4 ng/ml and a PSA density of > 0.1 will require prostate biopsy to rule out prostate cancer in order to be considered for study enrollment
- A subject with a prostate nodule will require biopsy to exclude cancer diagnosis
- Subject with a PSA > 10 ng/ml
- Subject taking LHRH analogs or anti-androgen drugs
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
The University of Alabama-Birmingham
Birmingham, Alabama, 35205
Brandon A Young, BS, 205-908-7315, bayoung@uabmc.edu
Jane E S Vines, MPH,MSN,RN,CCRP, 205-224-7324, jsnowden@uabmc.edu
- Recruiting
Florida Urology Partners
Brandon, Florida, 33511
James E Alver, MD, 813-685-0827, alverje@gmail.com
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Debbie Ryan, 480-342-1208, ryan.debra29@mayo.edu
Mitchell Humphreys, MD
- Recruiting
Vero Urology Center
Vero Beach, Florida, 32960
JOHN R ATWELL, MD, 772-569-7606, j.atwell@verourology.com
Andrew Prestini, PA-C, 772-569-7606, a.prestini@verourology.com
About this study
Official title: Study: A Prospective Evaluation of the Blue Halo BioMedical, LLC "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction
The Investigators will study a device for men in urinary retention secondary to Benign Prostatic Hyperplasia, BPH ,who are catheter dependent or who have a Post Void Residual > 350cc. The hypothesis is that the device will allow these participants to return to volitional voiding with a Post Void Residual <75 cc.
Read the detailed description
The indication for use of the Blue Halo Coil Catheter is to facilitate bladder drainage in adult male patients with urinary retention due to benign prostatic hyperplasia. The device is inserted for temporary use up to 28 days.
Study participants will have a history of Foley catheter use or self-catheterization to drain their bladder.Participants may include men in urinary retention with no prior intervention.
The hypothesis is that the Blue Halo Coil Catheter will reduce the post void residual to <75 cc with volitional voiding.
The Blue Halo Coil Catheter is comprised of a Coiled Retention portion with a guidewire accommodating tip, a short prostate catheter segment, and a pusher/delivery catheter segment, that when left in place allows for the temporary collection of urine prior to conversion to short segment without an external collection device. The tip of the Blue Halo Coil Catheter utilizes a horizontal coil retention device. A monofilament suture is attached to the prostate catheter segment to allow for ease of positioning and removal. The suture also allows for repositioning should the device slip back into the bladder.
- Conditions
- Urinary Retention
- Being tested
- blue halo coil catheter
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blue halo coil catheterDevice
device inserted with coil at the bladder and straight arm in the prostatic urethra proximal to the external sphincter
| Study group | Role | What they receive |
|---|---|---|
| Blue Halo Coil Catheter for Urinary Retention | Experimental | The indication for use of the Blue Halo Coil Catheter is to facilitate bladder drainage in adult male patients with urinary retention due to benign prostatic hyperplasia. The device is inserted for temporary use up to 28 days. Receives: Device: blue halo coil catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Post Void Residual from baseline to day 28 will be measured and reported
The primary effectiveness endpoint of the study is the number of subjects who were able to return to volitional voiding with a post void residual less then 75 cc during a 28-day study period.Post Void Residual will be measured by bladder ultrasound and reported as cc.
Measured: 28 days
Secondary outcomes (4)
Primary safety endpoint adverse event and device removal
The primary safety endpoint is the number of subjects who had an adverse event related to the Coil Catheter and required removal of the Coil Catheter with an alternative method to drain the bladder, such as an indwelling Foley catheter, or self-intermittent catheterization.
Measured: 28 days
Secondary Safety Endpoint 1, incidence of device encrustation at removal
The number of Blue Halo Coil Catheters that were visibly encrusted at the time of removal
Measured: 28 days
Secondary Safety Endpoint 2,urinary obstruction due to device migration
The number of participants who experienced urinary obstruction secondary to migration of the Blue Halo Coil Catheter, and required replacement of the device
Measured: 28 days
Secondary Safety Endpoint 3, incidence of clinically significant hematuria
The number of participants who experienced clinically significant gross hematuria that necessitated removal of the Blue Halo Coil Catheter and placement of a Foley catheter for bladder drainage
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Aug 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies 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
- Model description
- The Investigators are conducting a single-arm study with one-group posttest only design.Although this study is a non-randomized control trial, the one-arm design avoids selection and treatment diffusion (among other things). The comparator for the coil catheter is inferior and known to cause injury and infection. Therefore, researchers could not ethically randomly assign subjects to a control group that would receive the alternative device for the sake of comparison.
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blue Halo Biomedical, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714488
- Sponsor's protocol ID
- 19-010.3
- Acronym
- BlueHaloCoil
- Status last verified
- Jan 2024
- First submitted
- 20 Sep 2022
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: any Adverse Event (AE), Unanticipated AE will be shared with other researchers
Publications
Fontanarosa PB, Roush WR. Acute urinary retention. Emerg Med Clin North Am. 1988 Aug;6(3):419-37.
PubMed 3292220Samm BJ, Dmochowski RR. Urologic emergencies. Conditions affecting the kidney, ureter, bladder, prostate, and urethra. Postgrad Med. 1996 Oct;100(4):177-80, 183-4. doi: 10.3810/pgm.1996.10.100.
PubMed 8858090Andersen JT, Nickel JC, Marshall VR, Schulman CC, Boyle P. Finasteride significantly reduces acute urinary retention and need for surgery in patients with symptomatic benign prostatic hyperplasia. Urology. 1997 Jun;49(6):839-45. doi: 10.1016/s0090-4295(97)00185-4.
PubMed 9187688de la Rosette JJ, Beerlage HP, Debruyne FM. Role of temporary stents in alternative treatment of benign prostatic hyperplasia. J Endourol. 1997 Dec;11(6):467-72. doi: 10.1089/end.1997.11.467.
PubMed 9440858Williams G. Stents in the lower urinary tract. European Urology Update Series 1992. Vol l (1), p 82-87.
Devonec M, Dahlstrand C. Temporary urethral stenting after high-energy transurethral microwave thermotherapy of the prostate. World J Urol. 1998;16(2):120-3. doi: 10.1007/s003450050037.
PubMed 12073225Feneley RC, Hopley IB, Wells PN. Urinary catheters: history, current status, adverse events and research agenda. J Med Eng Technol. 2015;39(8):459-70. doi: 10.3109/03091902.2015.1085600. Epub 2015 Sep 18.
PubMed 26383168Hammond, G. A Prospective Evaluation of the Catheter Science M3 "Mini Catheter" for Patients with Prostatic Obstruction. AUA Poster Presentation MP73-06, San Francisco, California, May, 2018
Sabharwal S, Sabharwal S. Using Temporary Prostatic Stents to Eliminate Bacterial Colonization in Men with Chronic Indwelling Catheters: A Pilot Study. Cureus. 2018 Aug 16;10(8):e3152. doi: 10.7759/cureus.3152.
PubMed 30410822Garcia MM, Gulati S, Liepmann D, Stackhouse GB, Greene K, Stoller ML. Traditional Foley drainage systems--do they drain the bladder? J Urol. 2007 Jan;177(1):203-7; discussion 207. doi: 10.1016/j.juro.2006.08.101.
PubMed 17162043Shore ND, Dineen MK, Saslawsky MJ, Lumerman JH, Corica AP. A temporary intraurethral prostatic stent relieves prostatic obstruction following transurethral microwave thermotherapy. J Urol. 2007 Mar;177(3):1040-6. doi: 10.1016/j.juro.2006.10.059.
PubMed 17296408
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study: A Prospective Evaluation of the Blue Halo BioMedical, LLC "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction
- ClinicalTrials.gov ID
- NCT05714488
- Acronym / sponsor ID
- BlueHaloCoil / 19-010.3
- Conditions
- Urinary Retention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Blue Halo Biomedical, LLCUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Investigators will study a device for men in urinary retention secondary to Benign Prostatic Hyperplasia, BPH ,who are catheter dependent or who have a Post Void Residual > 350cc. The hypothesis is that the device will allow these participants to return to volitional voiding with a Post Void Residual <75 cc.
Detailed description
The indication for use of the Blue Halo Coil Catheter is to facilitate bladder drainage in adult male patients with urinary retention due to benign prostatic hyperplasia. The device is inserted for temporary use up to 28 days.
Study participants will have a history of Foley catheter use or self-catheterization to drain their bladder.Participants may include men in urinary retention with no prior intervention.
The hypothesis is that the Blue Halo Coil Catheter will reduce the post void residual to <75 cc with volitional voiding.
The Blue Halo Coil Catheter is comprised of a Coiled Retention portion with a guidewire accommodating tip, a short prostate catheter segment, and a pusher/delivery catheter segment, that when left in place allows for the temporary collection of urine prior to conversion to short segment without an external collection device. The tip of the Blue Halo Coil Catheter utilizes a horizontal coil retention device. A monofilament suture is attached to the prostate catheter segment to allow for ease of positioning and removal. The suture also allows for repositioning should the device slip back into the bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Investigators are conducting a single-arm study with one-group posttest only design.Although this study is a non-randomized control trial, the one-arm design avoids selection and treatment diffusion (among other things). The comparator for the coil catheter is inferior and known to cause injury and infection. Therefore, researchers could not ethically randomly assign subjects to a control group that would receive the alternative device for the sake of comparison.
| Arm | Type | Receives |
|---|---|---|
| Blue Halo Coil Catheter for Urinary Retention | Experimental | Device: blue halo coil catheterThe indication for use of the Blue Halo Coil Catheter is to facilitate bladder drainage in adult male patients with urinary retention due to benign prostatic hyperplasia. The device is inserted for temporary use up to 28 days. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male subjects > 50 years of age
- Able to provide consent
- Participants in urinary retention with post void residual > 350 cc
- Urinary retention is due to BPH with a prostate volume > 50cc or a prostatic urethral length of 5+ cm
- Subjects with a PSA > 4 ng/ml and a PSA density of 0.1 or less
Key exclusion criteria (8 listed)
- Inability to undergo bladder catheterization ( i.e. urethral stricture)
- Presence of gross hematuria
- Lack of cognitive ability to give consent or keep appointments
- History of Prostate Cancer
- Subject with a PSA > 4 ng/ml and a PSA density of > 0.1 will require prostate biopsy to rule out prostate cancer in order to be considered for study enrollment
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 |
|---|---|---|
| blue halo coil catheterdevice inserted with coil at the bladder and straight arm in the prostatic urethra proximal to the external sphincter | Device | Blue Halo Coil Catheter for Urinary Retention |
Primary outcome
The change in Post Void Residual from baseline to day 28 will be measured and reported
Time frame: 28 days
The primary effectiveness endpoint of the study is the number of subjects who were able to return to volitional voiding with a post void residual less then 75 cc during a 28-day study period.Post Void Residual will be measured by bladder ultrasound and reported as cc.
4 secondary outcomes
Primary safety endpoint adverse event and device removal
Time frame: 28 days
Secondary Safety Endpoint 1, incidence of device encrustation at removal
Time frame: 28 days
Secondary Safety Endpoint 2,urinary obstruction due to device migration
Time frame: 28 days
Secondary Safety Endpoint 3, incidence of clinically significant hematuria
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Results publication: PubMed 3292220Fontanarosa PB, Roush WR. Acute urinary retention. Emerg Med Clin North Am. 1988 Aug;6(3):419-37.
- Results publication: PubMed 8858090Samm BJ, Dmochowski RR. Urologic emergencies. Conditions affecting the kidney, ureter, bladder, prostate, and urethra. Postgrad Med. 1996 Oct;100(4):177-80, 183-4. doi: 10.3810/pgm.1996.10.100.
- Results publication: PubMed 9187688Andersen JT, Nickel JC, Marshall VR, Schulman CC, Boyle P. Finasteride significantly reduces acute urinary retention and need for surgery in patients with symptomatic benign prostatic hyperplasia. Urology. 1997 Jun;49(6):839-45. doi: 10.1016/s0090-4295(97)00185-4.
- Results publication: PubMed 9440858de la Rosette JJ, Beerlage HP, Debruyne FM. Role of temporary stents in alternative treatment of benign prostatic hyperplasia. J Endourol. 1997 Dec;11(6):467-72. doi: 10.1089/end.1997.11.467.
- Results publicationWilliams G. Stents in the lower urinary tract. European Urology Update Series 1992. Vol l (1), p 82-87.
- Results publication: PubMed 12073225Devonec M, Dahlstrand C. Temporary urethral stenting after high-energy transurethral microwave thermotherapy of the prostate. World J Urol. 1998;16(2):120-3. doi: 10.1007/s003450050037.
- Results publication: PubMed 26383168Feneley RC, Hopley IB, Wells PN. Urinary catheters: history, current status, adverse events and research agenda. J Med Eng Technol. 2015;39(8):459-70. doi: 10.3109/03091902.2015.1085600. Epub 2015 Sep 18.
- Results publicationHammond, G. A Prospective Evaluation of the Catheter Science M3 "Mini Catheter" for Patients with Prostatic Obstruction. AUA Poster Presentation MP73-06, San Francisco, California, May, 2018
- Results publication: PubMed 30410822Sabharwal S, Sabharwal S. Using Temporary Prostatic Stents to Eliminate Bacterial Colonization in Men with Chronic Indwelling Catheters: A Pilot Study. Cureus. 2018 Aug 16;10(8):e3152. doi: 10.7759/cureus.3152.
- Results publication: PubMed 17162043Garcia MM, Gulati S, Liepmann D, Stackhouse GB, Greene K, Stoller ML. Traditional Foley drainage systems--do they drain the bladder? J Urol. 2007 Jan;177(1):203-7; discussion 207. doi: 10.1016/j.juro.2006.08.101.
- Results publication: PubMed 17296408Shore ND, Dineen MK, Saslawsky MJ, Lumerman JH, Corica AP. A temporary intraurethral prostatic stent relieves prostatic obstruction following transurethral microwave thermotherapy. J Urol. 2007 Mar;177(3):1040-6. doi: 10.1016/j.juro.2006.10.059.
- Individual participant dataSharing planned: Yes. any Adverse Event (AE), Unanticipated AE will be shared with other researchers
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blue halo coil catheter in people with Urinary Retention, run by Blue Halo Biomedical, LLC at 4 sites 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GAMEEL B HODGE, MD (407-492-1683, bhodge@bluehalobiomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Post Void Residual from baseline to day 28 will be measured and reported (time frame: 28 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 NCT05714488, which also lists 11 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 10 Jan 2024.