Surgical Procedure, UnspecifiedNCT06637176
Examination of the Blood Supply of the Intestine Before Suturing the Ends of the Intestine.
An observational study of Surgical Procedure, Unspecified, run by University of Aarhus at 3 sites in Denmark.
Trial summary
In this non-interventional, multicenter study in the Central Denmark Region, the potential of assessing blood supply during colorectal surgery will be explored using a recognized and reliable laser technique called Laser Speckle Contrast Imaging. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Laser speckle contrast imaging
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Apr 2024to 10 Sep 2024
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be identified and included from the Regional Hospital Gødstrup, Viborg, and Randers.
Who may be able to join
- All patients undergoing any elective colorectal surgery with the potential formation of an extracorporeal anastomosis as part of the surgical procedure are eligible for inclusion, irrespective of the indication for surgery. Patients will be consecutively included, after informed consent.
Who cannot join
- In this clinical feasibility trial, exclusion criteria apply only in cases where the inclusion criteria are not met or if performing an extracorporeal anastomosis is not feasible during surgery. Otherwise, patients meeting the inclusion criteria will be considered eligible for participation in the trial.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Region hospital Gødstrup
Herning, 7400
Region Hospital Randers
Randers, 8900
Region Hospital Viborg
Viborg, 8800
About this study
Official title: Laser Speckle Contrast Imaging for Intraoperative Assessment of Anastomotic Perfusion
In this non-interventional, multicenter study in the Central Denmark Region, the potential of assessing blood supply during colorectal surgery will be explored using a recognized and reliable laser technique called Laser Speckle Contrast Imaging. The study aims to evaluate whether surgeons find this tool valuable in the decision-making process regarding where to perform the anastomosis during the operation.
Read the detailed description
Anastomotic leakage (AL) is among the most severe and feared postoperative complications of colorectal surgery as it is directly associated with an increase in mortality and morbidity. AL increases risk of local recurrence, decreases the 5-year survival rate, and impairs the patient's quality of life. Despite improvements in the surgical technique, AL continues to occur with high frequency. The cause of AL is considered multifactorial and several factors have shown association with increased risk of AL, although the complete pathogenesis is still unclear; It is recognized that one of the most important risk factors is inadequate blood supply to the anastomotic site, since optimal perfusion is essential for the healing of the anastomosis.
Currently, the assessment of the perfusion at the anastomotic site is based on a subjective clinical estimate by the surgeon (e.g., palpable pulsation of the arteries in the mesenterium, normal color of the intestine, bleeding from the surgical edges, and/or pulsatile bleeding from marginal arteries). However, these assessments are shown to lack objectivity, quantifiability, and predictive accuracy - even experienced surgeons underestimate the risk of AL.
Preventing AL is crucial for improving the outcomes of colorectal surgery. Studies have shown that understanding the state of microcirculation can help reduce the rate of AL. Therefore, having an accurate evaluation of local intestinal microcirculation is the first step in aiding surgeons to make informed decisions on the optimal anastomotic side.
Laser Speckle Contrast Imaging (LSCI) is a dye-free non-contact, non-invasive image-based method, capable of quantitative estimation of the local intestinal perfusion. Further, it allows for time-independent repeated measurements. LSCI uses laser light to generate a speckle pattern: When an object is in motion or contains moving particles such as blood cells, the interference between beams is affected, leading to variations in the phases and the creation of a dynamic speckle pattern. Based on the movements of the red blood cells, LSCI can be used to assess the blood flow within the tissue (microcirculation). Thus, LSCI cannot measure absolute flow but rather measures contrast changes and results are expressed as flux in arbitrary laser speckle perfusion units (LSPU), where higher LSPU values correspond to better tissue perfusion. LSCI is validated and used in small animal and human studies of the gastro-intestinal tract but has not yet been thoroughly tested in a true clinical setting.
LSCI has been utilized in various clinical contexts, including the gastrointestinal system, demonstrating ease and safety of use. However, there is only one similar study from 2019 in Japan where measurements were conducted on 8 patients undergoing colon surgery. The limitations of this study include its single-center nature, involvement of only one surgeon, and a lack of description regarding the surgeons\' perspectives on LSCI measurements - whether they consider it a useful tool in their intraoperative procedures. Recently, another study has been published employing LSCI to measure the colon intraoperatively. Nevertheless, this study utilizes a newly developed laparoscopic-based LSCI technique, and it compares surgeons\' subjective assessments of the technique. The findings indicate a high level of satisfaction, with 67% of surgeons expressing a willingness to make changes during surgery based on the images. Despite numerous clinical studies supporting the feasibility of LSCI, the literature on colon surgery lacks sufficient evidence to generalize the use of open LSCI equipment across all operating rooms as a tool for surgeons, despite its demonstrated potential.
It is hypothesized that LSCI is a method that could help surgeons evaluate and qualify the peri-operative intestinal microcirculation when anastomoses are formed.
The aim of this study is to investigate this hypothesis.
Study objectives:
- To provide a descriptive analysis of using LSCI during colorectal surgery to assess microcirculation in the intestines before and after anastomosis formation and evaluate the feasibility of the method.
- To assess the surgeon's subjective perception whether LSCI could be a useful tool to aid their decision-making during surgery.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Laser speckle contrast imaging
- Keywords
- microcirculation, surgical decision making, colon surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser speckle contrast imagingDevice
LSCI measurements will be taken before and after the formation of the anastomosis, with the surgeon blinded to the measurements to prevent any influence on surgical decision-making. The surgery will be performed as standard-of-care, unaffected by the LSCI measurements.
Following the surgery, the LSCI images will be presented to the surgeon, who will complete a questionnaire assessing whether the LSCI images, if presented perioperatively, would have influenced their decision regarding the location of the anastomotic site. Additionally, the surgeon will be asked if they consider LSCI to be a useful intraoperative tool in general. The surgical case and the series of LSCI images will also be presented to an independent surgeon, who will answer the same set of questions.
The LSCI measurements will be correlated with 30-day complication rates, with a specific focus on anastomotic leakage (AL).
Microcirculation is assessed using LSCI at a wavelength of 785 nm (MoorFLPI-2, Moor Instruments
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Colon Surgery with Extracorporeal Anastomosis | All individuals over 18 years old undergoing elective colon surgery with the formation of an extracorporeal anastomosis are eligible to participate, regardless of indication, comorbidities, or other conditions. Receives: Device: Laser speckle contrast imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis of using LSCI during colorectal surgery
The operation time and the time required to perform LSCI will be recorded. It is predefined that an acceptable LSCI duration will be a maximum of 5% of the total operation time.
Measured: from enrollment to surgery, aroundt 1-2 weeks.
Descriptive analysis of using LSCI during colorectal surgery
The number of times the sterile field is breached, the nature of each breach, and whether the breach can be rectified will be recorded. An acceptable sterile breach rate is predefined at 95%, and LSCI will only be considered feasible if 100% of the breaches are mendable.
Measured: from enrollment to surgery, aroundt 1-2 weeks.
Descriptive analysis of using LSCI during colorectal surgery
The number of LSCI measurement attempts made for each patient before a successful final measurement is obtained will be recorded. It is predefined that up to two attempts per successful LSCI measurement is considered acceptable.
Measured: from enrollment to surgery, aroundt 1-2 weeks.
Descriptive analysis of using LSCI during colorectal surgery
Surgeons will be asked, through a questionnaire, for their subjective opinion on whether LSCI in any way disturbs or interferes with the standard procedure in an unacceptable manner. It is predefined that LSCI will not be considered disruptive to the surgical procedure if more than 90% of surgeons find it acceptable.
Measured: from enrollment to surgery, aroundt 1-2 weeks.
Secondary outcomes (2)
Assess the surgeon's subjective perception whether LSCI could be a useful tool to aid their decision-making during surgery
By questionnaire, surgeons are asked their subjective opinion on whether LSCI is a useful intraoperative tool. The endpoint is expressed as the percentage of surgeons who subjectively find LSCI will be a useful tool.
Measured: from enrollment to surgery, aroundt 1-2 weeks.
Assess the surgeon's subjective perception whether LSCI could be a useful tool to aid their decision-making during surgery
By questionnaire, surgeons are asked their subjective opinion on whether they would have changed their intestinal resection line or anastomosis site if LSCI measurements were available during the operation. The endpoint is expressed at the percentage of surgeons who would have changed the resection line or anastomotic site if LSCI measurements had been available.
Measured: from enrollment to surgery, aroundt 1-2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Apr 2024
- Primary completion20 Aug 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Viborg Regional Hospital, Randers Regional Hospital, Gødstrup Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637176
- Sponsor's protocol ID
- 2314383
- Other IDs
- Doc.nr.: 2913575
- Status last verified
- Apr 2024
- First submitted
- 9 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are so few patients that Danish GDP data cannot be shared as it cannot be anonymized, which would be in violation of Danish data protection law.
Publications
Heeman W, Calon J, van der Bilt A, Pierie JEN, Pereboom I, van Dam GM, Boerma EC. Dye-free visualisation of intestinal perfusion using laser speckle contrast imaging in laparoscopic surgery: a prospective, observational multi-centre study. Surg Endosc. 2023 Dec;37(12):9139-9146. doi: 10.1007/s00464-023-10493-0. Epub 2023 Oct 9.
PubMed 37814165Kojima S, Sakamoto T, Nagai Y, Matsui Y, Nambu K, Masamune K. Laser Speckle Contrast Imaging for Intraoperative Quantitative Assessment of Intestinal Blood Perfusion During Colorectal Surgery: A Prospective Pilot Study. Surg Innov. 2019 Jun;26(3):293-301. doi: 10.1177/1553350618823426. Epub 2019 Jan 13.
PubMed 30638132Paramasivam R, Kristensen NM, Ambrus R, Stavsetra M, Orntoft MB, Madsen AH. Laser speckle contrast imaging for intraoperative assessment of intestinal microcirculation in normo- and hypovolemic circulation in a porcine model. Eur Surg Res. 2023 Dec 7. doi: 10.1159/000535525. Online ahead of print.
PubMed 38061337
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Speckle Contrast Imaging for Intraoperative Assessment of Anastomotic Perfusion
- ClinicalTrials.gov ID
- NCT06637176
- Acronym / sponsor ID
- 2314383
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- microcirculation, surgical decision making, colon surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Viborg Regional Hospital, Randers Regional Hospital, Gødstrup Hospital
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 15 Oct 2024 (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.
In this non-interventional, multicenter study in the Central Denmark Region, the potential of assessing blood supply during colorectal surgery will be explored using a recognized and reliable laser technique called Laser Speckle Contrast Imaging. The study aims to evaluate whether surgeons find this tool valuable in the decision-making process regarding where to perform the anastomosis during the operation.
Detailed description
Anastomotic leakage (AL) is among the most severe and feared postoperative complications of colorectal surgery as it is directly associated with an increase in mortality and morbidity. AL increases risk of local recurrence, decreases the 5-year survival rate, and impairs the patient's quality of life. Despite improvements in the surgical technique, AL continues to occur with high frequency. The cause of AL is considered multifactorial and several factors have shown association with increased risk of AL, although the complete pathogenesis is still unclear; It is recognized that one of the most important risk factors is inadequate blood supply to the anastomotic site, since optimal perfusion is essential for the healing of the anastomosis.
Currently, the assessment of the perfusion at the anastomotic site is based on a subjective clinical estimate by the surgeon (e.g., palpable pulsation of the arteries in the mesenterium, normal color of the intestine, bleeding from the surgical edges, and/or pulsatile bleeding from marginal arteries). However, these assessments are shown to lack objectivity, quantifiability, and predictive accuracy - even experienced surgeons underestimate the risk of AL.
Preventing AL is crucial for improving the outcomes of colorectal surgery. Studies have shown that understanding the state of microcirculation can help reduce the rate of AL. Therefore, having an accurate evaluation of local intestinal microcirculation is the first step in aiding surgeons to make informed decisions on the optimal anastomotic side.
Laser Speckle Contrast Imaging (LSCI) is a dye-free non-contact, non-invasive image-based method, capable of quantitative estimation of the local intestinal perfusion. Further, it allows for time-independent repeated measurements. LSCI uses laser light to generate a speckle pattern: When an object is in motion or contains moving particles such as blood cells, the interference between beams is affected, leading to variations in the phases and the creation of a dynamic speckle pattern. Based on the movements of the red blood cells, LSCI can be used to assess the blood flow within the tissue (microcirculation). Thus, LSCI cannot measure absolute flow but rather measures contrast changes and results are expressed as flux in arbitrary laser speckle perfusion units (LSPU), where higher LSPU values correspond to better tissue perfusion. LSCI is validated and used in small animal and human studies of the gastro-intestinal tract but has not yet been thoroughly tested in a true clinical setting.
LSCI has been utilized in various clinical contexts, including the gastrointestinal system, demonstrating ease and safety of use. However, there is only one similar study from 2019 in Japan where measurements were conducted on 8 patients undergoing colon surgery. The limitations of this study include its single-center nature, involvement of only one surgeon, and a lack of description regarding the surgeons\' perspectives on LSCI measurements - whether they consider it a useful tool in their intraoperative procedures. Recently, another study has been published employing LSCI to measure the colon intraoperatively. Nevertheless, this study utilizes a newly developed laparoscopic-based LSCI technique, and it compares surgeons\' subjective assessments of the technique. The findings indicate a high level of satisfaction, with 67% of surgeons expressing a willingness to make changes during surgery based on the images. Despite numerous clinical studies supporting the feasibility of LSCI, the literature on colon surgery lacks sufficient evidence to generalize the use of open LSCI equipment across all operating rooms as a tool for surgeons, despite its demonstrated potential.
It is hypothesized that LSCI is a method that could help surgeons evaluate and qualify the peri-operative intestinal microcirculation when anastomoses are formed.
The aim of this study is to investigate this hypothesis.
Study objectives:
- To provide a descriptive analysis of using LSCI during colorectal surgery to assess microcirculation in the intestines before and after anastomosis formation and evaluate the feasibility of the method.
- To assess the surgeon's subjective perception whether LSCI could be a useful tool to aid their decision-making during surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: Colon Surgery with Extracorporeal Anastomosis | – | Device: Laser speckle contrast imagingAll individuals over 18 years old undergoing elective colon surgery with the formation of an extracorporeal anastomosis are eligible to participate, regardless of indication, comorbidities, or other conditions. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be identified and included from the Regional Hospital Gødstrup, Viborg, and Randers.
Key inclusion criteria (1 listed)
- All patients undergoing any elective colorectal surgery with the potential formation of an extracorporeal anastomosis as part of the surgical procedure are eligible for inclusion, irrespective of the indication for surgery. Patients will be consecutively included, after informed consent.
Key exclusion criteria (1 listed)
- In this clinical feasibility trial, exclusion criteria apply only in cases where the inclusion criteria are not met or if performing an extracorporeal anastomosis is not feasible during surgery. Otherwise, patients meeting the inclusion criteria will be considered eligible for participation in the trial.
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 |
|---|---|---|
| Laser speckle contrast imagingLSCI measurements will be taken before and after the formation of the anastomosis, with the surgeon blinded to the measurements to prevent any influence on surgical decision-making. The surgery will be performed as standard-of-care, unaffected by the LSCI measurements. Following the surgery, the LSCI images will be presented to the surgeon, who will complete a questionnaire assessing whether the LSCI images, if presented perioperatively, would have influenced their decision regarding the location of the anastomotic site. Additionally, the surgeon will be asked if they consider LSCI to be a useful intraoperative tool in general. The surgical case and the series of LSCI images will also be presented to an independent surgeon, who will answer the same set of questions. The LSCI measurements will be correlated with 30-day complication rates, with a specific focus on anastomotic leakage (AL). Microcirculation is assessed using LSCI at a wavelength of 785 nm (MoorFLPI-2, Moor Instruments | Device | Group 1: Colon Surgery with Extracorporeal Anastomosis |
Primary outcome
Descriptive analysis of using LSCI during colorectal surgery
Time frame: from enrollment to surgery, aroundt 1-2 weeks.
The operation time and the time required to perform LSCI will be recorded. It is predefined that an acceptable LSCI duration will be a maximum of 5% of the total operation time.
Descriptive analysis of using LSCI during colorectal surgery
Time frame: from enrollment to surgery, aroundt 1-2 weeks.
The number of times the sterile field is breached, the nature of each breach, and whether the breach can be rectified will be recorded. An acceptable sterile breach rate is predefined at 95%, and LSCI will only be considered feasible if 100% of the breaches are mendable.
Descriptive analysis of using LSCI during colorectal surgery
Time frame: from enrollment to surgery, aroundt 1-2 weeks.
The number of LSCI measurement attempts made for each patient before a successful final measurement is obtained will be recorded. It is predefined that up to two attempts per successful LSCI measurement is considered acceptable.
Descriptive analysis of using LSCI during colorectal surgery
Time frame: from enrollment to surgery, aroundt 1-2 weeks.
Surgeons will be asked, through a questionnaire, for their subjective opinion on whether LSCI in any way disturbs or interferes with the standard procedure in an unacceptable manner. It is predefined that LSCI will not be considered disruptive to the surgical procedure if more than 90% of surgeons find it acceptable.
2 secondary outcomes
Assess the surgeon's subjective perception whether LSCI could be a useful tool to aid their decision-making during surgery
Time frame: from enrollment to surgery, aroundt 1-2 weeks.
Assess the surgeon's subjective perception whether LSCI could be a useful tool to aid their decision-making during surgery
Time frame: from enrollment to surgery, aroundt 1-2 weeks.
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 23 Oct 2024.
- Results publication: PubMed 37814165Heeman W, Calon J, van der Bilt A, Pierie JEN, Pereboom I, van Dam GM, Boerma EC. Dye-free visualisation of intestinal perfusion using laser speckle contrast imaging in laparoscopic surgery: a prospective, observational multi-centre study. Surg Endosc. 2023 Dec;37(12):9139-9146. doi: 10.1007/s00464-023-10493-0. Epub 2023 Oct 9.
- Results publication: PubMed 30638132Kojima S, Sakamoto T, Nagai Y, Matsui Y, Nambu K, Masamune K. Laser Speckle Contrast Imaging for Intraoperative Quantitative Assessment of Intestinal Blood Perfusion During Colorectal Surgery: A Prospective Pilot Study. Surg Innov. 2019 Jun;26(3):293-301. doi: 10.1177/1553350618823426. Epub 2019 Jan 13.
- Results publication: PubMed 38061337Paramasivam R, Kristensen NM, Ambrus R, Stavsetra M, Orntoft MB, Madsen AH. Laser speckle contrast imaging for intraoperative assessment of intestinal microcirculation in normo- and hypovolemic circulation in a porcine model. Eur Surg Res. 2023 Dec 7. doi: 10.1159/000535525. Online ahead of print.
- Individual participant dataSharing planned: No. There are so few patients that Danish GDP data cannot be shared as it cannot be anonymized, which would be in violation of Danish data protection law.
Related trials for Surgical Procedure, Unspecified
Recruiting
Improving Surgical Communication for Patients in Wisconsin
Surgeons, Surgical Procedure, Unspecified
Active, not recruitingObservational study
Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Department of Anesthesia at PHC
Surgical Procedure, Unspecified, Intensive Care Units (ICUs)
RecruitingPhase 4
A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
Fracture Arm, Fracture Closed of Lower End of Forearm, Unspecified
Not yet recruitingPhase 4
Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy
Minimally Invasive Surgical Procedures, Abnormal Uterine Bleeding, Unspecified
Recruiting
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
Critical Illness, Surgical Procedure, Unspecified
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Procedure, Unspecified, run by University of Aarhus at 3 sites in Denmark.
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 1 inclusion and 1 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 23 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 3 sites in Denmark. 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?
Descriptive analysis of using LSCI during colorectal surgery (time frame: from enrollment to surgery, aroundt 1-2 weeks.). The study lists 4 primary outcomes in all. 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 NCT06637176, 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 23 Oct 2024.