Right Colon CancerNTLC75-ITANCT07834385
Mechanical Resistance Curves of the NTLC75 Linear Stapler During Barcelona Ileotransverse Anastomosis
An observational study of Right Colon Cancer, run by University Hospital of Split at 1 site in Croatia.
Trial summary
This prospective single-center pilot cohort will include 40 consecutive adults undergoing elective right colectomy with a Barcelona ileotransverse anastomosis using an NTLC75/SR75 linear stapler. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Colon Cancer
- What is being tested?
- Passive External NTLC75 Handle-Signal Recording
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Oct 2026to 29 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adults scheduled for elective right colectomy for operable right-sided colon cancer with planned primary Barcelona ileotransverse anastomosis using NTLC75/SR75.
Who may be able to join
- Age 18 years or older
- Elective right colectomy for histologically confirmed or clinically or radiologically suspected operable right-sided colon cancer
- Planned primary Barcelona ileotransverse anastomosis using NTLC75/SR75
- Capacity to understand the study and provide written informed consent
Who cannot join
- Emergency surgery
- No planned or performed primary anastomosis
- Another anastomotic technique or stapler model
- Withdrawal or inability to consent
- Intraoperative change of plan preventing the planned measurement procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site
University Hospital of Split, Department of Surgery
Split, 21000
Ognjen Barčot, MD, PhD, +385 21 556 691, ognjen.barcot@kbsplit.hr
About this study
Official title: Relative Mechanical Resistance Curves of the NTLC75 Linear Stapler During Barcelona Ileotransverse Anastomosis After Right Colectomy: A Prospective Observational Pilot Study
This prospective single-center pilot cohort will include 40 consecutive adults undergoing elective right colectomy with a Barcelona ileotransverse anastomosis using an NTLC75/SR75 linear stapler. A sensor mounted externally on the stapler handle will record relative mechanical signals during two calibration closures without firing and two standard stapler activations. The main objectives are to obtain at least 35 technically valid final cross-stapling recordings and to estimate the association between the normalized final maximum signal and C-reactive protein on postoperative day 3. Clinical treatment is unchanged and follow-up continues through postoperative day 90.
Read the detailed description
Two close-only calibration measurements will be recorded once on double-walled small bowel and colon located on the resection-specimen side, outside the tumor and resection margins, with the anvil toward the mesentery, without firing or consuming additional reloads. The first standard activation forms the ileotransverse anastomotic channel without cross-stapling, with the anvil in the colon and reload jaw in the small bowel. The final closure is oriented with the device tip toward the small bowel so that knife travel proceeds from colon to small bowel and crosses two existing staple lines. The surgeon measures flattened tissue lengths and both cross-stapling distances with a sterile ruler to the nearest whole millimeter. Raw signals are preserved; forward and return branches are resampled to 200 normalized-time points. The signal is not calibrated as absolute force, is not shown to the surgeon and does not influence care. Other curve features and clinical outcomes are exploratory.
- Conditions
- Right Colon Cancer
- Being tested
- Passive External NTLC75 Handle-Signal Recording
- Keywords
- NTLC75, Ileotransverse anastomosis, Barcelona technique, Linear stapler, Cross-stapling, Mechanical signal, C-reactive protein, Feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive External NTLC75 Handle-Signal RecordingOther
An external DF9-40 sensor mounted on the NTLC75 handle passively records relative mechanical signals. One close-only calibration recording is obtained on double-walled small bowel and one on double-walled colon on the resection-specimen side, outside the tumor and resection margins, with the anvil toward the mesentery, without firing. Signals are also recorded during standard ITA channel formation (anvil in colon; reload jaw in small bowel; no cross-stapling) and final closure (tip toward small bowel; knife travel from colon to small bowel across two existing staple lines). The signal is not shown to the surgeon and does not affect clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Elective Right Colectomy Cohort | Adults undergoing elective right colectomy with a Barcelona ileotransverse anastomosis using NTLC75/SR75 as standard clinical care. Relative mechanical signals are recorded passively during two close-only calibration closures without firing and two standard stapler activations. Receives: Other: Passive External NTLC75 Handle-Signal Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With a Technically Valid Final Cross-Stapling Signal Record
Number and percentage of all 40 enrolled participants with a complete and technically valid final cross-stapling signal record. A valid record includes a complete forward branch, an identifiable reference return branch, no peak-obscuring saturation, no loss of sensor contact, and successful application of the locked signal-processing algorithm. Missing or invalid records remain in the denominator. Prespecified feasibility target: at least 35 of 40 participants.
Measured: Intraoperative, during the final cross-stapling activation
C-Reactive Protein Concentration on Postoperative Day 3 in Relation to the Normalized Final Maximum Signal
Routine-care serum C-reactive protein in mg/L, analyzed continuously in association with the normalized maximum amplitude of the final cross-stapling forward branch using a scatterplot, Pearson or Spearman correlation, and simple linear regression.
Measured: Postoperative day 3
Secondary outcomes (29)
CloseMax During Small-Bowel Close-Only Calibration
Maximum baseline-corrected relative signal amplitude during complete stapler closure on the double-walled small bowel located on the resection-specimen side, without firing. Reported in relative signal units.
Measured: Intraoperative, during the small-bowel close-only calibration
Maximum Signal Amplitude During ITA and Final Cross-Stapling Activations
Maximum baseline-corrected amplitude of each forward and return signal branch, calculated separately for the ileotransverse anastomotic-channel and final cross-stapling activations. Reported in relative signal units.
Measured: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Inter-Rater Agreement for Manual Curve Classification
Two independent raters blinded to C-reactive protein values and clinical outcomes classify technical validity, curve morphology, sticking, and irregularity for the ileotransverse anastomotic-channel and final cross-stapling recordings. Agreement between the two initial categorical ratings is quantified using Cohen's kappa before consensus resolution.
Measured: Through study completion and before database lock, an anticipated 16 months
C-Reactive Protein Concentration
Routine-care serum C-reactive protein concentration recorded separately on postoperative days 1 and 3 and reported in mg/L. The prespecified association between postoperative-day-3 CRP and the normalized final cross-stapling maximum remains the second primary outcome.
Measured: Postoperative days 1 and 3
Highest Clavien-Dindo Complication Grade
Highest Clavien-Dindo grade assigned to any postoperative complication experienced by each participant through postoperative day 90. Participants without a complication are recorded as having no Clavien-Dindo complication.
Measured: From the index operation through postoperative day 90
Participants With Anastomosis-Related Events
Number and percentage of participants with anastomotic leak, anastomotic bleeding, perianastomotic collection or abscess, anastomosis-related radiologic or endoscopic intervention, reoperation, or surgical revision. Each event type is reported separately.
Measured: From the index operation through postoperative day 90
Length of Postoperative Hospital Stay
Number of calendar days from the index operation to discharge from the index hospitalization.
Measured: From the index operation to discharge from the index hospitalization, assessed through postoperative day 90
CloseMax During Colon Close-Only Calibration
Maximum baseline-corrected relative signal amplitude during complete stapler closure on the double-walled colon located on the resection-specimen side, without firing. Reported in relative signal units.
Measured: Intraoperative, during the colon close-only calibration
CloseMax During Ileotransverse Anastomotic Channel Formation
Maximum baseline-corrected relative signal amplitude during the closing phase preceding the standard stapler activation used to form the ileotransverse anastomotic channel without cross-stapling. Reported in relative signal units.
Measured: Intraoperative, during the stapler activation forming the ileotransverse anastomotic channel
CloseMax During Final Cross-Stapling
Maximum baseline-corrected relative signal amplitude during the closing phase preceding the final cross-stapling activation. Reported in relative signal units.
Measured: Intraoperative, during the final cross-stapling activation
Normalized Time to Maximum Signal Amplitude
Position of the maximum baseline-corrected amplitude within each signal branch, expressed as a percentage of that branch's total duration from 0% to 100%. Calculated separately for the forward and return branches of both activations.
Measured: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Signal-Branch Duration During ITA and Final Cross-Stapling Activations
Actual elapsed duration of each forward and return signal branch, calculated separately for the ileotransverse anastomotic-channel and final cross-stapling activations. Reported in seconds from the preserved raw timestamps.
Measured: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Signal Peak Count During ITA and Final Cross-Stapling Activations
Number of signal peaks identified by the locked signal-processing algorithm in each 200-point normalized-time branch. Calculated separately for the forward and return branches of both activations.
Measured: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Maximum Signal Slope During ITA and Final Cross-Stapling Activations
Maximum positive slope of each 200-point normalized-time signal branch, calculated using the locked signal-processing algorithm. Reported in relative signal units per normalized-time point and calculated separately for both activations.
Measured: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Area Under the Signal Curve During ITA and Final Cross-Stapling Activations
Area under each baseline-corrected 200-point normalized-time signal branch, calculated separately for the forward and return branches of both activations. Reported in relative signal units multiplied by normalized time.
Measured: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Signal Amplitude Variability During ITA and Final Cross-Stapling Activations
Standard deviation of the baseline-corrected amplitudes across each 200-point normalized-time signal branch. Calculated separately for the forward and return branches of both activations and reported in relative signal units.
Measured: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Leukocyte Count
Routine-care peripheral blood leukocyte count recorded separately on postoperative days 1 and 3 and reported as ×10^9/L.
Measured: Postoperative days 1 and 3
Neutrophil Count
Routine-care peripheral blood absolute neutrophil count recorded separately on postoperative days 1 and 3 and reported as ×10^9/L.
Measured: Postoperative days 1 and 3
Lymphocyte Count
Routine-care peripheral blood absolute lymphocyte count recorded separately on postoperative days 1 and 3 and reported as ×10^9/L.
Measured: Postoperative days 1 and 3
Neutrophil-to-Lymphocyte Ratio
Neutrophil-to-lymphocyte ratio calculated from the absolute neutrophil and lymphocyte counts obtained on the same postoperative day. Recorded separately on postoperative days 1 and 3 and reported as a unitless ratio.
Measured: Postoperative days 1 and 3
Serum Albumin Concentration
Routine-care serum albumin concentration recorded separately on postoperative days 1 and 3 and reported in g/L.
Measured: Postoperative days 1 and 3
Serum Creatinine Concentration
Routine-care serum creatinine concentration recorded separately on postoperative days 1 and 3 and reported in µmol/L.
Measured: Postoperative days 1 and 3
Estimated Glomerular Filtration Rate
Laboratory-reported estimated glomerular filtration rate recorded separately on postoperative days 1 and 3 and reported in mL/min/1.73 m².
Measured: Postoperative days 1 and 3
Participants With a Major Postoperative Complication
Number and percentage of participants experiencing at least one major postoperative complication, defined as Clavien-Dindo grade III, IV, or V.
Measured: From the index operation through postoperative day 90
Comprehensive Complication Index Score
Comprehensive Complication Index score calculated from all postoperative complications experienced by each participant through postoperative day 90. Reported on the standard continuous scale from 0, indicating no complication, to 100, indicating death.
Measured: From the index operation through postoperative day 90
Participants With All-Cause Readmission Within 30 Days
Number and percentage of participants with at least one unplanned all-cause hospital readmission by postoperative day 30.
Measured: From discharge after the index hospitalization through postoperative day 30
Participants Undergoing Reoperation Within 30 Days
Number and percentage of participants undergoing at least one unplanned surgical reoperation for any cause by postoperative day 30.
Measured: From the index operation through postoperative day 30
All-Cause Mortality Within 30 Days
Number and percentage of participants who die from any cause by postoperative day 30.
Measured: From the index operation through postoperative day 30
All-Cause Mortality Within 90 Days
Number and percentage of participants who die from any cause by postoperative day 90.
Measured: From the index operation through postoperative day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion3 Nov 2027 (estimated)
- Study completion29 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Colon CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ognjen Barčot, MD, PhD, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834385
- Sponsor's protocol ID
- NTLC75-PILOT-01
- Acronym
- NTLC75-ITA
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient-level data will not be made public because the small single-center surgical cohort carries a material re-identification risk.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Mechanical Resistance Curves of the NTLC75 Linear Stapler During Barcelona Ileotransverse Anastomosis After Right Colectomy: A Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT07834385
- Acronym / sponsor ID
- NTLC75-ITA / NTLC75-PILOT-01
- Conditions
- Right Colon Cancer
- Keywords
- NTLC75, Ileotransverse anastomosis, Barcelona technique, Linear stapler, Cross-stapling, Mechanical signal, C-reactive protein, Feasibility
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 3 Nov 2027 (estimated)
- Study completion
- 29 Jan 2028 (estimated)
- First posted
- 22 Sep 2026 (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 prospective single-center pilot cohort will include 40 consecutive adults undergoing elective right colectomy with a Barcelona ileotransverse anastomosis using an NTLC75/SR75 linear stapler. A sensor mounted externally on the stapler handle will record relative mechanical signals during two calibration closures without firing and two standard stapler activations. The main objectives are to obtain at least 35 technically valid final cross-stapling recordings and to estimate the association between the normalized final maximum signal and C-reactive protein on postoperative day 3. Clinical treatment is unchanged and follow-up continues through postoperative day 90.
Detailed description
Two close-only calibration measurements will be recorded once on double-walled small bowel and colon located on the resection-specimen side, outside the tumor and resection margins, with the anvil toward the mesentery, without firing or consuming additional reloads. The first standard activation forms the ileotransverse anastomotic channel without cross-stapling, with the anvil in the colon and reload jaw in the small bowel. The final closure is oriented with the device tip toward the small bowel so that knife travel proceeds from colon to small bowel and crosses two existing staple lines. The surgeon measures flattened tissue lengths and both cross-stapling distances with a sterile ruler to the nearest whole millimeter. Raw signals are preserved; forward and return branches are resampled to 200 normalized-time points. The signal is not calibrated as absolute force, is not shown to the surgeon and does not influence care. Other curve features and clinical outcomes are exploratory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Right Colectomy Cohort | – | Other: Passive External NTLC75 Handle-Signal RecordingAdults undergoing elective right colectomy with a Barcelona ileotransverse anastomosis using NTLC75/SR75 as standard clinical care. Relative mechanical signals are recorded passively during two close-only calibration closures without firing and two standard stapler activations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults scheduled for elective right colectomy for operable right-sided colon cancer with planned primary Barcelona ileotransverse anastomosis using NTLC75/SR75.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Elective right colectomy for histologically confirmed or clinically or radiologically suspected operable right-sided colon cancer
- Planned primary Barcelona ileotransverse anastomosis using NTLC75/SR75
- Capacity to understand the study and provide written informed consent
Key exclusion criteria (5 listed)
- Emergency surgery
- No planned or performed primary anastomosis
- Another anastomotic technique or stapler model
- Withdrawal or inability to consent
- Intraoperative change of plan preventing the planned measurement procedure
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 |
|---|---|---|
| Passive External NTLC75 Handle-Signal RecordingAn external DF9-40 sensor mounted on the NTLC75 handle passively records relative mechanical signals. One close-only calibration recording is obtained on double-walled small bowel and one on double-walled colon on the resection-specimen side, outside the tumor and resection margins, with the anvil toward the mesentery, without firing. Signals are also recorded during standard ITA channel formation (anvil in colon; reload jaw in small bowel; no cross-stapling) and final closure (tip toward small bowel; knife travel from colon to small bowel across two existing staple lines). The signal is not shown to the surgeon and does not affect clinical care. | Other | Elective Right Colectomy Cohort |
Primary outcome
Participants With a Technically Valid Final Cross-Stapling Signal Record
Time frame: Intraoperative, during the final cross-stapling activation
Number and percentage of all 40 enrolled participants with a complete and technically valid final cross-stapling signal record. A valid record includes a complete forward branch, an identifiable reference return branch, no peak-obscuring saturation, no loss of sensor contact, and successful application of the locked signal-processing algorithm. Missing or invalid records remain in the denominator. Prespecified feasibility target: at least 35 of 40 participants.
C-Reactive Protein Concentration on Postoperative Day 3 in Relation to the Normalized Final Maximum Signal
Time frame: Postoperative day 3
Routine-care serum C-reactive protein in mg/L, analyzed continuously in association with the normalized maximum amplitude of the final cross-stapling forward branch using a scatterplot, Pearson or Spearman correlation, and simple linear regression.
29 secondary outcomes
CloseMax During Small-Bowel Close-Only Calibration
Time frame: Intraoperative, during the small-bowel close-only calibration
Maximum Signal Amplitude During ITA and Final Cross-Stapling Activations
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Inter-Rater Agreement for Manual Curve Classification
Time frame: Through study completion and before database lock, an anticipated 16 months
C-Reactive Protein Concentration
Time frame: Postoperative days 1 and 3
Highest Clavien-Dindo Complication Grade
Time frame: From the index operation through postoperative day 90
Participants With Anastomosis-Related Events
Time frame: From the index operation through postoperative day 90
Length of Postoperative Hospital Stay
Time frame: From the index operation to discharge from the index hospitalization, assessed through postoperative day 90
CloseMax During Colon Close-Only Calibration
Time frame: Intraoperative, during the colon close-only calibration
CloseMax During Ileotransverse Anastomotic Channel Formation
Time frame: Intraoperative, during the stapler activation forming the ileotransverse anastomotic channel
CloseMax During Final Cross-Stapling
Time frame: Intraoperative, during the final cross-stapling activation
Normalized Time to Maximum Signal Amplitude
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Signal-Branch Duration During ITA and Final Cross-Stapling Activations
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Signal Peak Count During ITA and Final Cross-Stapling Activations
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Maximum Signal Slope During ITA and Final Cross-Stapling Activations
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Area Under the Signal Curve During ITA and Final Cross-Stapling Activations
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Signal Amplitude Variability During ITA and Final Cross-Stapling Activations
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Leukocyte Count
Time frame: Postoperative days 1 and 3
Neutrophil Count
Time frame: Postoperative days 1 and 3
Lymphocyte Count
Time frame: Postoperative days 1 and 3
Neutrophil-to-Lymphocyte Ratio
Time frame: Postoperative days 1 and 3
Serum Albumin Concentration
Time frame: Postoperative days 1 and 3
Serum Creatinine Concentration
Time frame: Postoperative days 1 and 3
Estimated Glomerular Filtration Rate
Time frame: Postoperative days 1 and 3
Participants With a Major Postoperative Complication
Time frame: From the index operation through postoperative day 90
Comprehensive Complication Index Score
Time frame: From the index operation through postoperative day 90
Participants With All-Cause Readmission Within 30 Days
Time frame: From discharge after the index hospitalization through postoperative day 30
Participants Undergoing Reoperation Within 30 Days
Time frame: From the index operation through postoperative day 30
All-Cause Mortality Within 30 Days
Time frame: From the index operation through postoperative day 30
All-Cause Mortality Within 90 Days
Time frame: From the index operation through postoperative day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. Patient-level data will not be made public because the small single-center surgical cohort carries a material re-identification risk.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Colon Cancer, run by University Hospital of Split at 1 site in Croatia.
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 5 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: opening soon, as of the sponsor's last update on 22 Sep 2026. 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 Croatia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ognjen Barčot, MD, PhD (+385 21 556 691, ognjen.barcot@kbsplit.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With a Technically Valid Final Cross-Stapling Signal Record (time frame: Intraoperative, during the final cross-stapling activation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.