Parastomal HerniaNCT03972553
Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques
A study testing Sugarbaker technique for repairing parastomal hernia and Keyhole technique for repairing parastomal hernia in people with Parastomal Hernia, run by Clayton Petro at 1 site in United States.
Trial summary
This will be a randomized controlled trial comparing the incidence of radiographic hernia recurrence 2 years after parastomal hernia repair utilizing the retro-muscular Sugarbaker technique compared to the retro-muscular keyhole mesh technique. The primary endpoint will be recurrence at two years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Sugarbaker technique for repairing parastomal hernia and Keyhole technique for repairing parastomal hernia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2019to 27 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is willing and able to give informed consent
- Patient has one parastomal hernia
- Patient is willing to undergo mesh-based repair
- Patient is considered eligible to undergo open retromuscular repair without ostomy reversal
- The patient can tolerate general anesthesia
- Repair being performed in an elective situation
Who cannot join
- The subject is <18 years of age
- Patient has more than one stoma
- The patient is unable to give informed consent
- Patient is not willing to undergo mesh-based repair due to any reason
- Patient not eligible for open retromuscular repair without ostomy reversal
- Patient is unable to tolerate general anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Center for Abdominal Core Health
Cleveland, Ohio, 44195
About this study
Official title: Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques: A Registry-Based Randomized Controlled Trial
This will be a randomized controlled trial comparing the incidence of radiographic hernia recurrence 2 years after parastomal hernia repair utilizing the retro-muscular Sugarbaker technique compared to the retro-muscular keyhole mesh technique. The primary endpoint will be recurrence at two years. Secondary endpoints will be the incidence of mesh-related complications, all 30-day complication rates, and hospital length of stay. Patients eligible for the study will be 18 years or older with a parastomal hernia that requires open repair retromuscular repair without ostomy reversal as determined by one of five hernia surgeons who will participate in this study at the investigators' institution. All patients will be marked for a new stoma site preoperatively. Patients who have insufficient bowel length suitable for either technique will be excluded intraoperatively. Patients enrolled in the study will be entered in the Americas Hernia Society Quality Collaborative database by the attending surgeon. The database houses patient demographics, medical comorbidities, operative details, and postoperative outcomes - all entered by the attending surgeon.
Read the detailed description
Recent estimates approximate that 120,000 ostomies are created yearly, with an overall prevalence greater than 800,000. Parastomal hernia formation is the most common complication thereof, as most reviews acknowledge a rate of 50%, which increases to 75% for patients with a waist circumference >100cm. As patients live longer and rates of obesity climb, the sequelae of parastomal hernias do as well, including difficulty fitting stoma appliances, parastomal skin breakdown, pain, and obstructive episodes - all negatively impacting the patient's quality of life and compelling them to seek repair.
Recent data from the Americas Hernia Society Quality Collaborative (AHSQC) - a quality improvement hernia registry of surgeon-entered patient demographics, operative details, and outcomes - found that only 22% of stomas were reversible at the time of their parastomal hernia operation.[7] So in the vast majority of cases, the surgeon must decide the optimal technique for repair in the presence of a persistent stoma. Decision-making includes open versus laparoscopic approaches, stoma re-siting versus leaving it in situ, use of mesh, and mesh orientation relative to the bowel. The same AHSQC analysis found that mesh is used in 94% of repairs, and almost 80% are repaired open, likely due to the need for repair of a concomitant midline incisional hernia that frequently exists. As a high-volume hernia center, the investigators' preference has been to perform an open retromuscular repair with a transversus abdominis release (TAR) and retromuscular mesh placement, allowing for reinforcement of the midline, stoma, and prior stoma site if the stoma was re-sited. The stoma can be brought through a keyhole incision in the retromuscular mesh. The investigators' hernia recurrence rate at just 13-months mean follow-up was previously found to be 11%. A more recent audit of parastomal hernia repairs among the investigators using the aforementioned "keyhole" technique with a minimum of 1-year follow-up found a 17% rate of radiographic recurrence and 33% "composite" recurrence rate - patients who feel a bulge, regardless of their radiographic results. Recently, Pauli et al. reported the results of a novel technique for parastomal hernia repair at the 2018 International Hernia Congress with exciting early results. The technique is similar to the investigators' approach with a bilateral transversus abdominis release and placement of a retromuscular mesh reinforcement. However, rather than bringing the stoma through a keyhole defect in the mesh, it is draped over the mesh in the retromuscular space akin to a Sugarbaker repair offsetting the defect in the mesh and the fascia. Six surgeons reported their results of 44 patients with a mean follow-up of 10 months, with a 4.5% (n=2) recurrence rate, with no reports of mesh erosion or stoma necrosis. Given the excellent early results of this novel approach, the investigators hypothesize that the retromuscular Sugarbaker technique would dramatically reduce hernia recurrence compared to the traditional keyhole repair.
- Conditions
- Parastomal Hernia
- Being tested
- Sugarbaker technique for repairing parastomal hernia, Keyhole technique for repairing parastomal hernia
- Keywords
- Sugarbaker, keyhole, Open parastomal hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugarbaker technique for repairing parastomal herniaProcedure or surgery
The bowel will be brought through the peritoneum lateral to the edge of the retromuscular mesh and then draped over the mesh before bringing it through the anterior fascia medially.
Keyhole technique for repairing parastomal herniaProcedure or surgery
The bowel will be brought through defects in the posterior rectus sheath or contiguous peritoneum, mesh, and anterior fascia.
| Study group | Role | What they receive |
|---|---|---|
| Sugarbaker | Other | For the Sugarbaker group, the bowel will be brought through the peritoneum lateral to the edge of the retromuscular mesh and then draped over the mesh before bringing it through the anterior fascia medially. Receives: Procedure: Sugarbaker technique for repairing parastomal hernia |
| Keyhole | Other | For the Keyhole group the stoma will be taken down and rematured through a cruciate incision (keyhole) Receives: Procedure: Keyhole technique for repairing parastomal hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic hernia recurrence 2 years after parastomal hernia repair
To compare the incidence of radiographic hernia recurrence 2 years after parastomal hernia repair utilizing a retromuscular Sugarbaker technique compared to the retromuscular keyhole mesh technique.
Measured: Two years after the last surgery
Secondary outcomes (3)
Incidence of mesh-related complications
To compare the incidence of mesh-related complications between the two study groups.
Measured: Two years after the last surgery
30-day complication rates
To compare all 30-day complication rates for the two study groups.
Measured: 30 days after the last surgery
Hospital length-of-stay
To compare hospital length-of-stay for the two study groups.
Measured: An average of 1 week after the last surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start25 Apr 2019
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Parastomal HerniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clayton Petro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Clayton Petro, The Cleveland Clinic
- Investigators
- Clayton Petro, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972553
- Sponsor's protocol ID
- 19-398
- Status last verified
- Nov 2023
- First submitted
- 28 May 2019
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Turnbull GB. Ostomy statistics: the $64,000 question. Ostomy Wound Manage. 2003 Jun;49(6):22-3. No abstract available.
PubMed 12874481Hotouras A, Murphy J, Thaha M, Chan CL. The persistent challenge of parastomal herniation: a review of the literature and future developments. Colorectal Dis. 2013 May;15(5):e202-14. doi: 10.1111/codi.12156.
PubMed 23374759Carne PW, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg. 2003 Jul;90(7):784-93. doi: 10.1002/bjs.4220.
PubMed 12854101De Raet J, Delvaux G, Haentjens P, Van Nieuwenhove Y. Waist circumference is an independent risk factor for the development of parastomal hernia after permanent colostomy. Dis Colon Rectum. 2008 Dec;51(12):1806-9. doi: 10.1007/s10350-008-9366-5. Epub 2008 May 16.
PubMed 18483825Gavigan T, Stewart T, Matthews B, Reinke C. Patients Undergoing Parastomal Hernia Repair Using the Americas Hernia Society Quality Collaborative: A Prospective Cohort Study. J Am Coll Surg. 2018 Oct;227(4):393-403.e1. doi: 10.1016/j.jamcollsurg.2018.07.658. Epub 2018 Aug 4.
PubMed 30081081Timmermans L, Deerenberg EB, Lamme B, Jeekel J, Lange JF. Parastomal hernia is an independent risk factor for incisional hernia in patients with end colostomy. Surgery. 2014 Jan;155(1):178-83. doi: 10.1016/j.surg.2013.06.014. Epub 2013 Nov 12.
PubMed 24238119Raigani S, Criss CN, Petro CC, Prabhu AS, Novitsky YW, Rosen MJ. Single-center experience with parastomal hernia repair using retromuscular mesh placement. J Gastrointest Surg. 2014 Sep;18(9):1673-7. doi: 10.1007/s11605-014-2575-4. Epub 2014 Jun 19.
PubMed 24944155Maskal SM, Ellis RC, Fafaj A, Costanzo A, Thomas JD, Prabhu AS, Krpata DM, Beffa LRA, Tu C, Zheng X, Miller BT, Rosen MJ, Petro CC. Open Retromuscular Sugarbaker vs Keyhole Mesh Placement for Parastomal Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2024 Sep 1;159(9):982-989. doi: 10.1001/jamasurg.2024.1686.
PubMed 38865142Miller BT, Krpata DM, Petro CC, Beffa LRA, Carbonell AM, Warren JA, Poulose BK, Tu C, Prabhu AS, Rosen MJ. Biologic vs Synthetic Mesh for Parastomal Hernia Repair: Post Hoc Analysis of a Multicenter Randomized Controlled Trial. J Am Coll Surg. 2022 Sep 1;235(3):401-409. doi: 10.1097/XCS.0000000000000275. Epub 2022 Aug 10.
PubMed 35588504Miller BT, Thomas JD, Tu C, Costanzo A, Beffa LRA, Krpata DM, Prabhu AS, Rosen MJ, Petro CC. Comparing Sugarbaker versus keyhole mesh technique for open retromuscular parastomal hernia repair: study protocol for a registry-based randomized controlled trial. Trials. 2022 Apr 4;23(1):251. doi: 10.1186/s13063-022-06207-x.
PubMed 35379311
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parastomal Hernia Repair Utilizing the Retromuscular Sugarbaker Versus Keyhole Mesh Techniques: A Registry-Based Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03972553
- Acronym / sponsor ID
- 19-398
- Conditions
- Parastomal Hernia
- Keywords
- Sugarbaker, keyhole, Open parastomal hernia repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Clayton PetroUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 3 Jun 2019 (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.
This will be a randomized controlled trial comparing the incidence of radiographic hernia recurrence 2 years after parastomal hernia repair utilizing the retro-muscular Sugarbaker technique compared to the retro-muscular keyhole mesh technique. The primary endpoint will be recurrence at two years. Secondary endpoints will be the incidence of mesh-related complications, all 30-day complication rates, and hospital length of stay. Patients eligible for the study will be 18 years or older with a parastomal hernia that requires open repair retromuscular repair without ostomy reversal as determined by one of five hernia surgeons who will participate in this study at the investigators' institution. All patients will be marked for a new stoma site preoperatively. Patients who have insufficient bowel length suitable for either technique will be excluded intraoperatively. Patients enrolled in the study will be entered in the Americas Hernia Society Quality Collaborative database by the attending surgeon. The database houses patient demographics, medical comorbidities, operative details, and postoperative outcomes - all entered by the attending surgeon.
Detailed description
Recent estimates approximate that 120,000 ostomies are created yearly, with an overall prevalence greater than 800,000. Parastomal hernia formation is the most common complication thereof, as most reviews acknowledge a rate of 50%, which increases to 75% for patients with a waist circumference >100cm. As patients live longer and rates of obesity climb, the sequelae of parastomal hernias do as well, including difficulty fitting stoma appliances, parastomal skin breakdown, pain, and obstructive episodes - all negatively impacting the patient's quality of life and compelling them to seek repair.
Recent data from the Americas Hernia Society Quality Collaborative (AHSQC) - a quality improvement hernia registry of surgeon-entered patient demographics, operative details, and outcomes - found that only 22% of stomas were reversible at the time of their parastomal hernia operation.[7] So in the vast majority of cases, the surgeon must decide the optimal technique for repair in the presence of a persistent stoma. Decision-making includes open versus laparoscopic approaches, stoma re-siting versus leaving it in situ, use of mesh, and mesh orientation relative to the bowel. The same AHSQC analysis found that mesh is used in 94% of repairs, and almost 80% are repaired open, likely due to the need for repair of a concomitant midline incisional hernia that frequently exists. As a high-volume hernia center, the investigators' preference has been to perform an open retromuscular repair with a transversus abdominis release (TAR) and retromuscular mesh placement, allowing for reinforcement of the midline, stoma, and prior stoma site if the stoma was re-sited. The stoma can be brought through a keyhole incision in the retromuscular mesh. The investigators' hernia recurrence rate at just 13-months mean follow-up was previously found to be 11%. A more recent audit of parastomal hernia repairs among the investigators using the aforementioned "keyhole" technique with a minimum of 1-year follow-up found a 17% rate of radiographic recurrence and 33% "composite" recurrence rate - patients who feel a bulge, regardless of their radiographic results. Recently, Pauli et al. reported the results of a novel technique for parastomal hernia repair at the 2018 International Hernia Congress with exciting early results. The technique is similar to the investigators' approach with a bilateral transversus abdominis release and placement of a retromuscular mesh reinforcement. However, rather than bringing the stoma through a keyhole defect in the mesh, it is draped over the mesh in the retromuscular space akin to a Sugarbaker repair offsetting the defect in the mesh and the fascia. Six surgeons reported their results of 44 patients with a mean follow-up of 10 months, with a 4.5% (n=2) recurrence rate, with no reports of mesh erosion or stoma necrosis. Given the excellent early results of this novel approach, the investigators hypothesize that the retromuscular Sugarbaker technique would dramatically reduce hernia recurrence compared to the traditional keyhole repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugarbaker | Other | Procedure: Sugarbaker technique for repairing parastomal herniaFor the Sugarbaker group, the bowel will be brought through the peritoneum lateral to the edge of the retromuscular mesh and then draped over the mesh before bringing it through the anterior fascia medially. |
| Keyhole | Other | Procedure: Keyhole technique for repairing parastomal herniaFor the Keyhole group the stoma will be taken down and rematured through a cruciate incision (keyhole) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient is willing and able to give informed consent
- Patient has one parastomal hernia
- Patient is willing to undergo mesh-based repair
- Patient is considered eligible to undergo open retromuscular repair without ostomy reversal
- The patient can tolerate general anesthesia
Key exclusion criteria (6 listed)
- The subject is <18 years of age
- Patient has more than one stoma
- The patient is unable to give informed consent
- Patient is not willing to undergo mesh-based repair due to any reason
- Patient not eligible for open retromuscular repair without ostomy reversal
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 |
|---|---|---|
| Sugarbaker technique for repairing parastomal herniaThe bowel will be brought through the peritoneum lateral to the edge of the retromuscular mesh and then draped over the mesh before bringing it through the anterior fascia medially. | Procedure or surgery | Sugarbaker |
| Keyhole technique for repairing parastomal herniaThe bowel will be brought through defects in the posterior rectus sheath or contiguous peritoneum, mesh, and anterior fascia. | Procedure or surgery | Keyhole |
Primary outcome
Radiographic hernia recurrence 2 years after parastomal hernia repair
Time frame: Two years after the last surgery
To compare the incidence of radiographic hernia recurrence 2 years after parastomal hernia repair utilizing a retromuscular Sugarbaker technique compared to the retromuscular keyhole mesh technique.
3 secondary outcomes
Incidence of mesh-related complications
Time frame: Two years after the last surgery
30-day complication rates
Time frame: 30 days after the last surgery
Hospital length-of-stay
Time frame: An average of 1 week after the last surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Background: PubMed 12874481Turnbull GB. Ostomy statistics: the $64,000 question. Ostomy Wound Manage. 2003 Jun;49(6):22-3. No abstract available.
- Background: PubMed 23374759Hotouras A, Murphy J, Thaha M, Chan CL. The persistent challenge of parastomal herniation: a review of the literature and future developments. Colorectal Dis. 2013 May;15(5):e202-14. doi: 10.1111/codi.12156.
- Background: PubMed 12854101Carne PW, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg. 2003 Jul;90(7):784-93. doi: 10.1002/bjs.4220.
- Background: PubMed 18483825De Raet J, Delvaux G, Haentjens P, Van Nieuwenhove Y. Waist circumference is an independent risk factor for the development of parastomal hernia after permanent colostomy. Dis Colon Rectum. 2008 Dec;51(12):1806-9. doi: 10.1007/s10350-008-9366-5. Epub 2008 May 16.
- Background: PubMed 30081081Gavigan T, Stewart T, Matthews B, Reinke C. Patients Undergoing Parastomal Hernia Repair Using the Americas Hernia Society Quality Collaborative: A Prospective Cohort Study. J Am Coll Surg. 2018 Oct;227(4):393-403.e1. doi: 10.1016/j.jamcollsurg.2018.07.658. Epub 2018 Aug 4.
- Background: PubMed 24238119Timmermans L, Deerenberg EB, Lamme B, Jeekel J, Lange JF. Parastomal hernia is an independent risk factor for incisional hernia in patients with end colostomy. Surgery. 2014 Jan;155(1):178-83. doi: 10.1016/j.surg.2013.06.014. Epub 2013 Nov 12.
- Background: PubMed 24944155Raigani S, Criss CN, Petro CC, Prabhu AS, Novitsky YW, Rosen MJ. Single-center experience with parastomal hernia repair using retromuscular mesh placement. J Gastrointest Surg. 2014 Sep;18(9):1673-7. doi: 10.1007/s11605-014-2575-4. Epub 2014 Jun 19.
- Derived from this study: PubMed 38865142Maskal SM, Ellis RC, Fafaj A, Costanzo A, Thomas JD, Prabhu AS, Krpata DM, Beffa LRA, Tu C, Zheng X, Miller BT, Rosen MJ, Petro CC. Open Retromuscular Sugarbaker vs Keyhole Mesh Placement for Parastomal Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2024 Sep 1;159(9):982-989. doi: 10.1001/jamasurg.2024.1686.
- Derived from this study: PubMed 35588504Miller BT, Krpata DM, Petro CC, Beffa LRA, Carbonell AM, Warren JA, Poulose BK, Tu C, Prabhu AS, Rosen MJ. Biologic vs Synthetic Mesh for Parastomal Hernia Repair: Post Hoc Analysis of a Multicenter Randomized Controlled Trial. J Am Coll Surg. 2022 Sep 1;235(3):401-409. doi: 10.1097/XCS.0000000000000275. Epub 2022 Aug 10.
- Derived from this study: PubMed 35379311Miller BT, Thomas JD, Tu C, Costanzo A, Beffa LRA, Krpata DM, Prabhu AS, Rosen MJ, Petro CC. Comparing Sugarbaker versus keyhole mesh technique for open retromuscular parastomal hernia repair: study protocol for a registry-based randomized controlled trial. Trials. 2022 Apr 4;23(1):251. doi: 10.1186/s13063-022-06207-x.
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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.
Clayton Petro, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugarbaker technique for repairing parastomal hernia and Keyhole technique for repairing parastomal hernia in people with Parastomal Hernia, run by Clayton Petro 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 6 inclusion and 6 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 4 Dec 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Radiographic hernia recurrence 2 years after parastomal hernia repair (time frame: Two years after the last surgery). 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 NCT03972553, which also lists 10 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 4 Dec 2023.