Hernia, InguinalMEFINCT05678465
MEsh FIxation in Laparoendoscopic Repair of Large M3 Inguinal Hernias
A study testing Non-fixation of the mesh and Fixation of the mesh in people with Hernia, Inguinal and Hernia, Direct Inguinal, run by Swissmed Hospital at 1 site in Poland.
Trial summary
The goal of this Multicenter Clinical Trial is to verify the hypothesis that non-fixation of the 3-D anatomical mesh (Dextile Anatomical Mesh or 3D Max Mesh) is non-inferior in terms of recurrence compared to fixation of lightweight, macroporous meshes in laparoendoscopic repairs of large M3 inguinal hernias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Inguinal, Hernia, Direct Inguinal
- What is being tested?
- Non-fixation of the mesh and Fixation of the mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2023to 12 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective groin hernia repair,
- M3 or M3+L1-3 (EHS classification) groin hernia confirmed during surgery
- eligibility to laparoendoscopic repair
- written informed consent
Who cannot join
- emergency surgery (incarcerated hernia)
- contaminated surgical field
- recurrent hernia
- extremely large scrotal hernia with the need of other forms of prevention of Abdominal Compartment Syndrome (botox injection, preoperative progressive pneumoperitoneum - PPP, bowel resection etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MEsh FIxation in Laparoendoscopic Repair of Large M3 Inguinal Hernias - Multicenter, Double-blinded, Randomized Controlled Trial.
The goal of this Multicenter Clinical Trial is to verify the hypothesis that non-fixation of the 3-D anatomical mesh (Dextile Anatomical Mesh or 3D Max Mesh) is non-inferior in terms of recurrence compared to fixation of lightweight, macroporous meshes in laparoendoscopic repairs of large M3 inguinal hernias.
Read the detailed description
INTRODUCTION International guidelines of groin hernia treatment strongly recommends to fixate the mesh in case of large M3 medial defects during laparoendoscopic approach (TAPP / TEP). Main purpose of fixation is to decrease recurrence rate which is alarmingly high in case of those defects. Recommendation was based on analysis of large German database (Herniamed). However, deeper look into those findings shows that most of TAPP and TEP procedures were performed with the use of lightweight, flat, macroporous meshes. In 2022 multidisciplinary team consisting of hernia surgeons and scientists from universities of technology conducted an experimental study with the use of 3d groin model to confirm or deny the hypothesis that fixation is not necessary in above cases. Study was conducted with the use of all 3-D anatomical meshes available on Polish market, as well as with flat, macroporous implants. Experiment showed that large, rigid and anatomically shaped meshes are able to maintain its position in groin without need of fixation. To confirm experimental results we decided to conduct large, multicentre, clinical study to evaluate necessity of mesh fixation of large, spatial, standard polypropylene implants.
STUDY HYPOTHESIS Non-fixation of spatial, standard polypropylene meshes is non-inferior as compared to fixation of flat, polypropylene lightweight meshes during TAPP / TEP procedures.
MATERIALS AND METHODS 11 large surgery centres in Poland having proficiency in laparoendoscopic groin hernia repairs (performing at least 80 TAPP/TEP a year) were recruited for this study. Before recruiting patients a two day "bootcamp" meeting was planned. Each centre designated one surgeon responsible for conducing the trial in its hospital and sent him/her to meeting. Recurrence rate in 12-month follow-up was set as a primary endpoint. Pain sensation (assessed with VAS scale) was made a secondary endpoint. Statistical analysis was performed by experts to adjust the sample sizes. The trial was planned as non-inferiority study with test power = 80%, p-value = 0,05 and threshold for clinical significance = 8%. Percentage loss was assumed at 10%. Recurrence rate was assumed 4% based on literature. Based on those assumptions minimal sample size in both arms was calculated at 83-102. Inclusion criteria: elective groin hernia repair, age > 18 years, male and female patients can participate, M3 or M3+L1-3 (EHS classification) groin hernia confirmed during surgery, eligibility to laparoendoscopic repair, written informed consent. Exclusion criteria: age <18 years, emergency surgery (incarcerated hernia), contaminated surgical field, extremely large scrotal hernia with the need of other forms of prevention of ACS (preoperative botox injection, bowel resection etc.) First arm (control group) will consist of patients repaired with the use of flat, macroporous, lightweight mesh fixated with histoacryl glue. Second arm will consist of patients repaired with the use of anatomically shaped, large, standard, polypropylene mesh (Dextile Anatomical Mesh - MEDTRONIC or 3D Max Mesh - BD) without the use of fixation material.
As M3 hernias are difficult to diagnose before the surgery, all patients planned for laparoendscopic repairs will be asked to participate in trial. During the surgery, when the defect size is measured, patient will be fully included in the study. After dissection of preperitoneal space (and establishing crucial checkpoints), surgeon will open envelope and find out the technique he will have to perform. Patients won't be aware of the method used during surgery. Unblinding will take place at the end of the trial. Pain will be measured during the hospital stay and then 7-days, 3-months and 12-months after surgery (VAS Scale). Follow up will be performed by Medical Assistant via phone call (also blinded to the method used). If any doubts occur, patient will be asked to come to ambulatory visit.
PREDICTED OUTCOMES Based on experimental study published in Surgical Endoscopy (Zamkowski et al., 2022) and own experience, we believe that recurrence rate in both arms will be on the same level. Those outcomes will be a strong argument for amending the guidelines in terms of mesh fixation. It would show that mesh fixation is not necessary if the proper, spatial mesh is used.
- Conditions
- Hernia, Inguinal, Hernia, Direct Inguinal
- Being tested
- Non-fixation of the mesh, Fixation of the mesh
- Keywords
- hernia, tapp, inguinal hernia, laparoendscopic repair, groin hernia, mesh
- Medical subject headings
- Hernia, Inguinal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-fixation of the meshProcedure or surgery
Also called 3D Max Mesh (BD), Dextile Anatomical Mesh (Medtronic)
3D-shaped, anatomical, standard, polypropylene mesh without fixation.
Fixation of the meshProcedure or surgery
Also called B Braun Optilene Mesh, BD SoftMesh
Glue fixation of lightweight, macroporous, polypropylene mesh.
| Study group | Role | What they receive |
|---|---|---|
| FIXATION | Experimental | Lightweight macroporous mesh at least 15x10cm will be placed in preperitoneal space and fixated with use of histoacryl glue.
Mesh - B Braun® Optilene Mesh® or BD® SoftMesh® Glue - Histoacryl® LapFix Receives: Procedure: Fixation of the mesh |
| NON-FIXATION | Experimental | Standard, 3-D, anatomical mesh will be placed in preperitoneal space without the use of fixating materials.
Mesh - BD® 3D Max® Mesh or Medtronic® Dextile Anatomical Mesh® Receives: Procedure: Non-fixation of the mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reccurence Rate
Reccurence in 1 year after surgery
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Feb 2023
- Primary completion30 Nov 2023
- Study completion12 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies 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
- Model description
- Patients in both arms will recieve intervention. First arm (mesh + fixation) serves also as control. Patients in second arm will be operated with mesh without fixation.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swissmed Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Klinika Chirurgii Ogólnej, Onkologicznej i Endokrynologicznej Szpitala Zespolonego w Kielcach, Oddział Chirurgii Ogólnej MCM Jonscher w Łodzi, Oddział Chirurgii Ogólnej i Onkologicznej Szpitala w Wejherowie, Klinika Chirurgii Ogólnej i Onkologicznej UM w Łodzi, Oddział Chirurgii Ogólnej, Małoinwazyjnej i Wieku Podeszłego Miejskiego Szpitala Zespolonego w Olsztynie, Oddział Chirurgii Ogólnej Regionalnego Centrum Zdrowia w Lubinie, Klinika Chirurgii Ogólnej, Wojskowy Instytut Medycyny Lotniczej w Warszawie, Oddział Chirurgii Ogólnej, SPOZ w Siedlcach, Oddział Chirurgii Ogólnej Szpitala w Puszczykowie, Oddział Chirurgii Ogólnej z Pododdziałem Urazowo-Ortopedycznym Szpitala w Szczytnie, Oddział Chirurgiczny Ogólny, Wojewódzki Szpital Specjalistyczny w Częstochowie
- Responsible party
- Principal investigator, Mateusz Zamkowski, Swissmed Hospital
- Investigators
- Mateusz Zamkowski, MD, PhD, Study chair, Swissmed HospitalMaciej Śmietański, Prof., Study director, Swissmed Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678465
- Sponsor's protocol ID
- MEFI TRIAL
- Acronym
- MEFI
- Status last verified
- Oct 2024
- First submitted
- 26 Dec 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be availble in English on a reasonable request.
Publications
Zamkowski M, Tomaszewska A, Lubowiecka I, Karbowski K, Smietanski M. Is mesh fixation necessary in laparoendoscopic techniques for M3 inguinal defects? An experimental study. Surg Endosc. 2023 Mar;37(3):1781-1788. doi: 10.1007/s00464-022-09699-5. Epub 2022 Oct 13.
PubMed 36229552HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.
PubMed 29330835Mayer F, Niebuhr H, Lechner M, Dinnewitzer A, Kohler G, Hukauf M, Fortelny RH, Bittner R, Kockerling F. When is mesh fixation in TAPP-repair of primary inguinal hernia repair necessary? The register-based analysis of 11,230 cases. Surg Endosc. 2016 Oct;30(10):4363-71. doi: 10.1007/s00464-016-4754-8. Epub 2016 Feb 17.
PubMed 26886454Novik B, Sandblom G, Ansorge C, Thorell A. Association of Mesh and Fixation Options with Reoperation Risk after Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study of 25,190 Totally Extraperitoneal and Transabdominal Preperitoneal Repairs. J Am Coll Surg. 2022 Mar 1;234(3):311-325. doi: 10.1097/XCS.0000000000000060.
PubMed 35213495Zamkowski M, Smietanski M. MEsh FIxation in Laparoendsocopic Repair of Large M3 inguinal hernias: multicenter, double-blinded, randomized controlled trial-study protocol for a MEFI Trial. Trials. 2023 Sep 5;24(1):572. doi: 10.1186/s13063-023-07601-9.
PubMed 37670376
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEsh FIxation in Laparoendoscopic Repair of Large M3 Inguinal Hernias - Multicenter, Double-blinded, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05678465
- Acronym / sponsor ID
- MEFI / MEFI TRIAL
- Conditions
- Hernia, Inguinal, Hernia, Direct Inguinal
- Keywords
- hernia, tapp, inguinal hernia, laparoendscopic repair, groin hernia, mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Swissmed HospitalUniversity, hospital or other
- Collaborators
- Klinika Chirurgii Ogólnej, Onkologicznej i Endokrynologicznej Szpitala Zespolonego w Kielcach, Oddział Chirurgii Ogólnej MCM Jonscher w Łodzi, Oddział Chirurgii Ogólnej i Onkologicznej Szpitala w Wejherowie, Klinika Chirurgii Ogólnej i Onkologicznej UM w Łodzi, Oddział Chirurgii Ogólnej, Małoinwazyjnej i Wieku Podeszłego Miejskiego Szpitala Zespolonego w Olsztynie, Oddział Chirurgii Ogólnej Regionalnego Centrum Zdrowia w Lubinie, Klinika Chirurgii Ogólnej, Wojskowy Instytut Medycyny Lotniczej w Warszawie, Oddział Chirurgii Ogólnej, SPOZ w Siedlcach, Oddział Chirurgii Ogólnej Szpitala w Puszczykowie, Oddział Chirurgii Ogólnej z Pododdziałem Urazowo-Ortopedycznym Szpitala w Szczytnie, Oddział Chirurgiczny Ogólny, Wojewódzki Szpital Specjalistyczny w Częstochowie
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 12 Oct 2024 (actual)
- First posted
- 10 Jan 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 goal of this Multicenter Clinical Trial is to verify the hypothesis that non-fixation of the 3-D anatomical mesh (Dextile Anatomical Mesh or 3D Max Mesh) is non-inferior in terms of recurrence compared to fixation of lightweight, macroporous meshes in laparoendoscopic repairs of large M3 inguinal hernias.
Detailed description
INTRODUCTION International guidelines of groin hernia treatment strongly recommends to fixate the mesh in case of large M3 medial defects during laparoendoscopic approach (TAPP / TEP). Main purpose of fixation is to decrease recurrence rate which is alarmingly high in case of those defects. Recommendation was based on analysis of large German database (Herniamed). However, deeper look into those findings shows that most of TAPP and TEP procedures were performed with the use of lightweight, flat, macroporous meshes. In 2022 multidisciplinary team consisting of hernia surgeons and scientists from universities of technology conducted an experimental study with the use of 3d groin model to confirm or deny the hypothesis that fixation is not necessary in above cases. Study was conducted with the use of all 3-D anatomical meshes available on Polish market, as well as with flat, macroporous implants. Experiment showed that large, rigid and anatomically shaped meshes are able to maintain its position in groin without need of fixation. To confirm experimental results we decided to conduct large, multicentre, clinical study to evaluate necessity of mesh fixation of large, spatial, standard polypropylene implants.
STUDY HYPOTHESIS Non-fixation of spatial, standard polypropylene meshes is non-inferior as compared to fixation of flat, polypropylene lightweight meshes during TAPP / TEP procedures.
MATERIALS AND METHODS 11 large surgery centres in Poland having proficiency in laparoendoscopic groin hernia repairs (performing at least 80 TAPP/TEP a year) were recruited for this study. Before recruiting patients a two day "bootcamp" meeting was planned. Each centre designated one surgeon responsible for conducing the trial in its hospital and sent him/her to meeting. Recurrence rate in 12-month follow-up was set as a primary endpoint. Pain sensation (assessed with VAS scale) was made a secondary endpoint. Statistical analysis was performed by experts to adjust the sample sizes. The trial was planned as non-inferiority study with test power = 80%, p-value = 0,05 and threshold for clinical significance = 8%. Percentage loss was assumed at 10%. Recurrence rate was assumed 4% based on literature. Based on those assumptions minimal sample size in both arms was calculated at 83-102. Inclusion criteria: elective groin hernia repair, age > 18 years, male and female patients can participate, M3 or M3+L1-3 (EHS classification) groin hernia confirmed during surgery, eligibility to laparoendoscopic repair, written informed consent. Exclusion criteria: age <18 years, emergency surgery (incarcerated hernia), contaminated surgical field, extremely large scrotal hernia with the need of other forms of prevention of ACS (preoperative botox injection, bowel resection etc.) First arm (control group) will consist of patients repaired with the use of flat, macroporous, lightweight mesh fixated with histoacryl glue. Second arm will consist of patients repaired with the use of anatomically shaped, large, standard, polypropylene mesh (Dextile Anatomical Mesh - MEDTRONIC or 3D Max Mesh - BD) without the use of fixation material.
As M3 hernias are difficult to diagnose before the surgery, all patients planned for laparoendscopic repairs will be asked to participate in trial. During the surgery, when the defect size is measured, patient will be fully included in the study. After dissection of preperitoneal space (and establishing crucial checkpoints), surgeon will open envelope and find out the technique he will have to perform. Patients won't be aware of the method used during surgery. Unblinding will take place at the end of the trial. Pain will be measured during the hospital stay and then 7-days, 3-months and 12-months after surgery (VAS Scale). Follow up will be performed by Medical Assistant via phone call (also blinded to the method used). If any doubts occur, patient will be asked to come to ambulatory visit.
PREDICTED OUTCOMES Based on experimental study published in Surgical Endoscopy (Zamkowski et al., 2022) and own experience, we believe that recurrence rate in both arms will be on the same level. Those outcomes will be a strong argument for amending the guidelines in terms of mesh fixation. It would show that mesh fixation is not necessary if the proper, spatial mesh is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients in both arms will recieve intervention. First arm (mesh + fixation) serves also as control. Patients in second arm will be operated with mesh without fixation.
| Arm | Type | Receives |
|---|---|---|
| FIXATION | Experimental | Procedure: Fixation of the meshLightweight macroporous mesh at least 15x10cm will be placed in preperitoneal space and fixated with use of histoacryl glue. Mesh - B Braun® Optilene Mesh® or BD® SoftMesh® Glue - Histoacryl® LapFix |
| NON-FIXATION | Experimental | Procedure: Non-fixation of the meshStandard, 3-D, anatomical mesh will be placed in preperitoneal space without the use of fixating materials. Mesh - BD® 3D Max® Mesh or Medtronic® Dextile Anatomical Mesh® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elective groin hernia repair,
- M3 or M3+L1-3 (EHS classification) groin hernia confirmed during surgery
- eligibility to laparoendoscopic repair
- written informed consent
Key exclusion criteria (4 listed)
- emergency surgery (incarcerated hernia)
- contaminated surgical field
- recurrent hernia
- extremely large scrotal hernia with the need of other forms of prevention of Abdominal Compartment Syndrome (botox injection, preoperative progressive pneumoperitoneum - PPP, bowel resection etc.)
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 |
|---|---|---|
| Non-fixation of the meshAlso: 3D Max Mesh (BD), Dextile Anatomical Mesh (Medtronic)3D-shaped, anatomical, standard, polypropylene mesh without fixation. | Procedure or surgery | NON-FIXATION |
| Fixation of the meshAlso: B Braun Optilene Mesh, BD SoftMeshGlue fixation of lightweight, macroporous, polypropylene mesh. | Procedure or surgery | FIXATION |
Primary outcome
Reccurence Rate
Time frame: 12-months
Reccurence in 1 year after 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 15 Oct 2024.
- Background: PubMed 36229552Zamkowski M, Tomaszewska A, Lubowiecka I, Karbowski K, Smietanski M. Is mesh fixation necessary in laparoendoscopic techniques for M3 inguinal defects? An experimental study. Surg Endosc. 2023 Mar;37(3):1781-1788. doi: 10.1007/s00464-022-09699-5. Epub 2022 Oct 13.
- Background: PubMed 29330835HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.
- Background: PubMed 26886454Mayer F, Niebuhr H, Lechner M, Dinnewitzer A, Kohler G, Hukauf M, Fortelny RH, Bittner R, Kockerling F. When is mesh fixation in TAPP-repair of primary inguinal hernia repair necessary? The register-based analysis of 11,230 cases. Surg Endosc. 2016 Oct;30(10):4363-71. doi: 10.1007/s00464-016-4754-8. Epub 2016 Feb 17.
- Background: PubMed 35213495Novik B, Sandblom G, Ansorge C, Thorell A. Association of Mesh and Fixation Options with Reoperation Risk after Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study of 25,190 Totally Extraperitoneal and Transabdominal Preperitoneal Repairs. J Am Coll Surg. 2022 Mar 1;234(3):311-325. doi: 10.1097/XCS.0000000000000060.
- Derived from this study: PubMed 37670376Zamkowski M, Smietanski M. MEsh FIxation in Laparoendsocopic Repair of Large M3 inguinal hernias: multicenter, double-blinded, randomized controlled trial-study protocol for a MEFI Trial. Trials. 2023 Sep 5;24(1):572. doi: 10.1186/s13063-023-07601-9.
- Individual participant dataSharing planned: Yes. Data will be availble in English on a reasonable request.
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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.
Mateusz Zamkowski, MD, PhD study chair
Swissmed Hospital
Maciej Śmietański, Prof. study director
Swissmed Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-fixation of the mesh and Fixation of the mesh in people with Hernia, Inguinal and Hernia, Direct Inguinal, run by Swissmed Hospital at 1 site in Poland.
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 4 inclusion and 4 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 15 Oct 2024. 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 Poland. 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?
Reccurence Rate (time frame: 12-months). 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 NCT05678465, which also lists 5 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 15 Oct 2024.