TrichiasisMTSSNCT03100747
Maximizing Trichiasis Surgery Success
A study testing Bilamellar 3 mm, Bilamellar 5 mm and Trabut 3 mm in people with Trichiasis and Surgery, run by University of North Carolina, Chapel Hill at 1 site in Ethiopia.
Trial summary
The purpose of this study is to determine whether the rate of post-operative trachomatous trichiasis differs significantly between bilamellar tarsal rotation surgery with an incision height of 3 mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and Trabut surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trichiasis, Surgery
- What is being tested?
- Bilamellar 3 mm, Bilamellar 5 mm and Trabut 3 mm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,914 participants
- Where
- 1 siteEthiopia
- Study dates
- 5 Apr 2017to 2 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one eyelid with previously unoperated upper eyelid trichiasis
- Willing to comply with all study procedures and be available for the duration of the study
Who cannot join
- Inability to provide independent, informed consent
- All eyes with previously unoperated trichiasis are phthisical
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Orbis Ethiopia
Hosa’ina, Southerns Nations, Nationalities, and Peoples' Region
About this study
Official title: Evaluating the Role of Incision Height in Trichiasis Surgery Outcomes
The purpose of this study is to determine whether the rate of post-operative trachomatous trichiasis differs significantly between bilamellar tarsal rotation surgery with an incision height of 3 mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and Trabut surgery.
Read the detailed description
In this trial the investigators will randomize 4,953 individuals with previously unoperated trichiasis on a 1:1:1 basis to bilamellar tarsal rotation trichiasis surgery with an incision height of 3 mm, bilamellar tarsal rotation trichiasis surgery with an incision height of 5 mm, or Trabut surgery. Participants will receive trichiasis surgery then will be followed at 1 day, 2 weeks, 6 weeks, and 12 months after surgery. Some participants may be asked to attend a follow-up visit at 3-6 months. The primary outcome is development of post-operative trachomatous trichiasis (PTT) within 12 months after surgery. Logistic regression analyses will be performed to compare the rates of PTT in the 3 versus 5 mm incision bilamellar tarsal rotation (BLTR) groups, in the 3 mm BLTR versus Trabut group, and in the 5 mm BLTR versus Trabut group, adjusting for demographic characteristics and pre-operative trichiasis severity.
- Conditions
- Trichiasis, Surgery
- Being tested
- Bilamellar 3 mm, Bilamellar 5 mm, Trabut 3 mm
- Medical subject headings
- Trichiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilamellar 3 mmProcedure or surgery
Also called Bilamellar Tarsal Rotation with 3 mm incision
Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin
Bilamellar 5 mmProcedure or surgery
Also called Bilamellar Tarsal Rotation with 5mm incision
Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin
Trabut 3 mmProcedure or surgery
Also called Trabut procedure with 3 mm incision
Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin
| Study group | Role | What they receive |
|---|---|---|
| Bilamellar 3 mm | Active comparator | Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 3 mm from the eyelid margin. Receives: Procedure: Bilamellar 3 mm |
| Bilamellar 5mm | Active comparator | Bilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 5 mm from the eyelid margin. Receives: Procedure: Bilamellar 5 mm |
| Trabut 3mm | Active comparator | Trabut surgery involves a partial-thickness incision through the upper eyelid parallel to the eyelid margin. For this surgery, the height of the incision will be assigned at 3 mm from the eyelid margin. Receives: Procedure: Trabut 3 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months
Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic. Outcomes will be evaluated at 6 weeks and 12 months. The first date of post-operative trichiasis will be used as the outcome.
Measured: 12 Months
Secondary outcomes (11)
Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks
Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic.
Measured: 6 Weeks
Severity of Post-Operative Trichiasis at 6 Weeks
Severity of post-operative trichiasis will be graded as mild, moderate, or severe based on number of eyelashes touching globe and number of eyelashes epilated.
Definitions for trichiasis severity are: Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10+ Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated
Measured: 6 Weeks
Severity of Post-Operative Trichiasis at 12 Months
Severity of post-operative trichiasis will be graded as mild, moderate, or severe based on number of eyelashes touching globe and number of eyelashes epilated.
Definitions for trichiasis severity are: Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10+ Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated
Measured: 12 Months
Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks
A field and photograph examiner will grade the presence of abnormality independently, using a standardized definition. For this analysis, mild will be combined with normal to create "no significant abnormality" and moderate and severe will be combined into a "moderate/severe contour abnormality" group. The photographic grade will serve as the primary grade for this measure.
Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length
Measured: 6 Weeks
Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months
A field and photograph examiner will grade the presence of abnormality independently. For this analysis, mild is combined with normal to create "no significant abnormality" and moderate and severe are combined into a "moderate/severe contour abnormality" group. The photographic grade will serve as the primary grade. The 12 month dichotomous photograph grade will be the main eyelid contour abnormality (ECA) outcome. Data from the last completed visit (6 weeks or 12 months) are used.
Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length
Measured: 12 Months
Severity of Eyelid Contour Abnormalities at 6 Weeks
Using the grades obtained in the outcome above, the eyelid contour abnormality will be reported as none, mild, moderate, or severe. This is a secondary outcome and will only utilize the photograph grade for this outcome.
Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length
Measured: 6 Weeks
Severity of Eyelid Contour Abnormalities at 12 Months
The eyelid contour abnormality will be reported as none, mild, moderate, or severe. This is a secondary outcome and will only utilize the photograph grade for this outcome.
Definitions for abnormality are: Mild: Vertical deviation from the natural contour, 1 mm in height (less than half the pupil height in daylight) and affecting 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour 2 mm in height (more than the pupil height in daylight) or a defect >2/3 of the horizontal eyelid length.
Measured: 12 Months
Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year
The severity of eyelid contour abnormality can lessen over time. The severity will be compared at 6 weeks and 12 months.
Measured: 12 months
Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks
Pyogenic granulomas occasionally develop after trichiasis surgery, and it is thought that these are a response to a foreign body, such as suture material or a jagged incision edge. The patient examiners will evaluate presence of granulomas, and all granulomas will be noted, regardless of size.
Measured: 6 weeks
Number of Eyes With Presence of Pyogenic Granulomas Within 12 Months
Pyogenic granulomas occasionally develop after trichiasis surgery, and it is thought that these are a response to a foreign body, such as suture material or a jagged incision edge. The patient examiners will evaluate presence of granulomas, and all granulomas will be noted, regardless of size. Data are included for both 6 weeks and 12 months.
Measured: up to 12 Months
Number of Eyes With Presence of Post-Operative Trichiasis Within 3 Years
Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic. Outcomes will be evaluated based on visits at 6 weeks, 12 months and/or Year 3.
Measured: up to 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start5 Apr 2017
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
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 (3)Papers the sponsor has linked to this study.
- Other trials for TrichiasisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4,914 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Orbis, National Eye Institute (NEI), University of Maryland, Baltimore
- Responsible party
- Sponsor
- Investigators
- Emily Gower, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100747
- Sponsor's protocol ID
- 16-2878
- Other IDs
- UG1EY025992
- Acronym
- MTSS
- Status last verified
- Oct 2023
- First submitted
- 27 Feb 2017
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared with researchers on an as requested basis after the primary results paper has been published. Interested researchers can contact the principal investigator by email in order to request data and provide a data analysis plan.
Publications
Gower EW, Sisay A, Bayissasse B, Seyum D, Weaver J, Munoz B, Keil AP, Bankoski A, Sullivan KM, Kana H, Admassu F, Tadesse D, Merbs SL. The impact of modified incision height and surgical procedure on trichiasis surgery outcomes: Results of the maximizing trichiasis surgery success (MTSS) randomized trial. PLoS Negl Trop Dis. 2024 Sep 3;18(9):e0012034. doi: 10.1371/journal.pntd.0012034. eCollection 2024 Sep.
PubMed 39226693Diallo AO, Bayissasse B, Sisay A, Seyum D, Weaver J, Munoz B, Merbs SL, Gower EW. Effectiveness of Trachomatous Trichiasis Case-identification Approaches in Ethiopia. Epidemiology. 2023 Nov 1;34(6):909-920. doi: 10.1097/EDE.0000000000001656. Epub 2023 Sep 26.
PubMed 37757880Bayissasse B, Sullivan KM, Merbs SL, Munoz B, Keil A, Sisay A, Singer A, Gower EW. Maximising trichiasis surgery success (MTSS) trial: rationale and design of a randomised controlled trial to improve trachomatous trichiasis surgical outcomes. BMJ Open. 2020 Mar 18;10(3):e036327. doi: 10.1136/bmjopen-2019-036327.
PubMed 32193277
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of Incision Height in Trichiasis Surgery Outcomes
- ClinicalTrials.gov ID
- NCT03100747
- Acronym / sponsor ID
- MTSS / 16-2878
- Conditions
- Trichiasis, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,914 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Orbis, National Eye Institute (NEI), University of Maryland, Baltimore
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 5 Dec 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 determine whether the rate of post-operative trachomatous trichiasis differs significantly between bilamellar tarsal rotation surgery with an incision height of 3 mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and Trabut surgery.
Detailed description
In this trial the investigators will randomize 4,953 individuals with previously unoperated trichiasis on a 1:1:1 basis to bilamellar tarsal rotation trichiasis surgery with an incision height of 3 mm, bilamellar tarsal rotation trichiasis surgery with an incision height of 5 mm, or Trabut surgery. Participants will receive trichiasis surgery then will be followed at 1 day, 2 weeks, 6 weeks, and 12 months after surgery. Some participants may be asked to attend a follow-up visit at 3-6 months. The primary outcome is development of post-operative trachomatous trichiasis (PTT) within 12 months after surgery. Logistic regression analyses will be performed to compare the rates of PTT in the 3 versus 5 mm incision bilamellar tarsal rotation (BLTR) groups, in the 3 mm BLTR versus Trabut group, and in the 5 mm BLTR versus Trabut group, adjusting for demographic characteristics and pre-operative trichiasis severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilamellar 3 mm | Active comparator | Procedure: Bilamellar 3 mmBilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 3 mm from the eyelid margin. |
| Bilamellar 5mm | Active comparator | Procedure: Bilamellar 5 mmBilamellar tarsal rotation trichiasis surgery involves a full-thickness incision through the upper eyelid. For this arm, the height of the incision will be assigned at 5 mm from the eyelid margin. |
| Trabut 3mm | Active comparator | Procedure: Trabut 3 mmTrabut surgery involves a partial-thickness incision through the upper eyelid parallel to the eyelid margin. For this surgery, the height of the incision will be assigned at 3 mm from the eyelid margin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least one eyelid with previously unoperated upper eyelid trichiasis
- Willing to comply with all study procedures and be available for the duration of the study
Key exclusion criteria (2 listed)
- Inability to provide independent, informed consent
- All eyes with previously unoperated trichiasis are phthisical
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 |
|---|---|---|
| Bilamellar 3 mmAlso: Bilamellar Tarsal Rotation with 3 mm incisionTrichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin | Procedure or surgery | Bilamellar 3 mm |
| Bilamellar 5 mmAlso: Bilamellar Tarsal Rotation with 5mm incisionTrichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin | Procedure or surgery | Bilamellar 5mm |
| Trabut 3 mmAlso: Trabut procedure with 3 mm incisionTrichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin | Procedure or surgery | Trabut 3mm |
Primary outcome
Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months
Time frame: 12 Months
Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic. Outcomes will be evaluated at 6 weeks and 12 months. The first date of post-operative trichiasis will be used as the outcome.
11 secondary outcomes
Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks
Time frame: 6 Weeks
Severity of Post-Operative Trichiasis at 6 Weeks
Time frame: 6 Weeks
Severity of Post-Operative Trichiasis at 12 Months
Time frame: 12 Months
Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks
Time frame: 6 Weeks
Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months
Time frame: 12 Months
Severity of Eyelid Contour Abnormalities at 6 Weeks
Time frame: 6 Weeks
Severity of Eyelid Contour Abnormalities at 12 Months
Time frame: 12 Months
Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year
Time frame: 12 months
Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks
Time frame: 6 weeks
Number of Eyes With Presence of Pyogenic Granulomas Within 12 Months
Time frame: up to 12 Months
Number of Eyes With Presence of Post-Operative Trichiasis Within 3 Years
Time frame: up to 3 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39226693Gower EW, Sisay A, Bayissasse B, Seyum D, Weaver J, Munoz B, Keil AP, Bankoski A, Sullivan KM, Kana H, Admassu F, Tadesse D, Merbs SL. The impact of modified incision height and surgical procedure on trichiasis surgery outcomes: Results of the maximizing trichiasis surgery success (MTSS) randomized trial. PLoS Negl Trop Dis. 2024 Sep 3;18(9):e0012034. doi: 10.1371/journal.pntd.0012034. eCollection 2024 Sep.
- Derived from this study: PubMed 37757880Diallo AO, Bayissasse B, Sisay A, Seyum D, Weaver J, Munoz B, Merbs SL, Gower EW. Effectiveness of Trachomatous Trichiasis Case-identification Approaches in Ethiopia. Epidemiology. 2023 Nov 1;34(6):909-920. doi: 10.1097/EDE.0000000000001656. Epub 2023 Sep 26.
- Derived from this study: PubMed 32193277Bayissasse B, Sullivan KM, Merbs SL, Munoz B, Keil A, Sisay A, Singer A, Gower EW. Maximising trichiasis surgery success (MTSS) trial: rationale and design of a randomised controlled trial to improve trachomatous trichiasis surgical outcomes. BMJ Open. 2020 Mar 18;10(3):e036327. doi: 10.1136/bmjopen-2019-036327.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared with researchers on an as requested basis after the primary results paper has been published. Interested researchers can contact the principal investigator by email in order to request data and provide a data analysis plan.
Related trials for Trichiasis
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
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.
Emily Gower, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilamellar 3 mm, Bilamellar 5 mm and Trabut 3 mm in people with Trichiasis and Surgery, run by University of North Carolina, Chapel Hill at 1 site in Ethiopia.
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 2 inclusion and 2 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 5 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 Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 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 Eyes With Presence of Post-Operative Trichiasis Within 12 Months (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 NCT03100747, which also lists 3 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 5 Dec 2023.