Esophageal CancerNCT03835273
Oesophagectomy and Chest Wall and Respiratory Function
An observational study of Esophageal Cancer and Esophagectomy, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Open surgery for esophageal cancer commonly involves large incisions in the chest, associated with a high rate of pulmonary complications (30-50%). Minimally invasive approach through keyhole surgery has been shown to reduce pulmonary infections by 20%. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Cancer, Esophagectomy, Respiratory Function Loss
- What is being tested?
- 3D motion capture system, Incentive spirometry and Questionnaires
- How many people
- 73 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 May 2019to 31 Aug 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Three cohorts will be studied, equal in size. A total of 100 patients will be included in this study. One hundred patients who have undergone oesophagectomy for oesophageal cancer more than a year ago, 60 patients who have undergone open surgery and 40 healthy volunteers will be included as a control group with no underlying respiratory disease and no previous history of upper gastrointestinal surgery. Patients who have undergone oesophagectomy will be identified from existing databases by the direct care team of the patient. Healthy volunteers will be recruited from Imperial College through paper adverts.
Who may be able to join
- Exposure group:
- Patients treated more than a year ago with oesophagectomy for oesophageal cancer, by an open approach.
- Patients able to understand and retain the information provided, thereby being able to give informed consent for inclusion in this study.
- Control group:
- Healthy volunteers with no underlying respiratory disease and no history of upper gastrointestinal surgery.
- Individuals able to understand and retain the information provided, thereby being able to give informed consent for inclusion in this study.
Who cannot join
- Any participant who lacks capacity or is unable to provide informed consent.
- Any participant younger than 18 or older than 90 years of age.
- Any patient with evidence of cancer recurrence or on-going postoperative complication at more than one year following surgery for oesophageal cancer.
- Any pregnant participant.
- unable to or excluded from performing spirometry or respiratory muscle strength testing (non-invasive testing)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Respiratory Function and Chest Wall Movement Following Oesophagectomy
Open surgery for esophageal cancer commonly involves large incisions in the chest, associated with a high rate of pulmonary complications (30-50%). Minimally invasive approach through keyhole surgery has been shown to reduce pulmonary infections by 20%. Enhanced recovery programmes are evidence-based protocols, developed to achieve early recovery after surgery with early mobilisation and chest physiotherapy and have been shown to reduce pulmonary complication rates as well. The investigators intend to objectively measure chest wall movement using 3D motion capture system as well as a wearable measurement system to monitor chest wall movement.
Read the detailed description
The study population consists of 40 healthy volunteers who have not received upper gastrointestinal surgery and 60 patients treated with surgery more than one year ago (open approach). Chest wall movement will be measured using a 3D optical motion system and the investigators will establish if inertial measurement units placed strategically on the chest wall are able to quantify chest expansion and lung capacity. Data will be acquired during different breathing patterns and during use of an incentive spirometry. Pulmonary function tests will be undertaken in all patients and the investigators will also collect clinical data concerning health-related quality of life and other concomitant medical conditions. The target outcome of this study is to determine whether the 3D motion capture and wearable systems are reliable in the measurement of chest wall movement after surgical removal of esophagus and the validity and patient acceptability of wearable system, as well as the ability of distinguishing open and minimally invasive surgical approach. A tailored physiotherapy may be developed following this study in order to improve chest wall movement and objectively measure this using the wearable system. This can then be implemented in a clinical trial to provide the evidence base to for patient-tailored physiotherapy following major cancer surgery and to optimise the respiratory function.
- Conditions
- Esophageal Cancer, Esophagectomy, Respiratory Function Loss
- Being tested
- 3D motion capture system, Incentive spirometry, Questionnaires
- Keywords
- Esophagectomy, Motion capture, Respiratory, Oesophageal cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D motion capture systemOther
Small reflective markers and inertia measurement units will be placed on the chest of the patients using hypoallergenic adhesive and a motion capture system will pick up a 3D image via these markers non-invasively.
Incentive spirometryOther
Incentive spirometry is a non-invasive device for assessment of pulmonary function.
QuestionnairesOther
Three validated, European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Oesophago-Gastric Module 25 (EORTC QLQ-OG25) and LASORS questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Fourty control participants who have not received upper gastrointestinal surgery. Receives: Other: 3D motion capture system; Other: Incentive spirometry; Other: Questionnaires | |
| Open surgery | Sixty patients who have undergone open removal of oesophagus more than one year ago. Receives: Other: 3D motion capture system; Other: Incentive spirometry; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest wall movement
Evaluation of changes in chest wall movement in patients who have undergone oesophagectomy more than a year ago (open surgery) and in healthy control participants. Reflective markers will be placed on the chest wall of the participant and chest wall movement will be detected by a 3D motion capture system using these markers. In addition, inertia measurement units will be applied next to the markers. Chest wall movement will be assessed during normal breathing, take and hold a deep breath and whilst performing incentive spirometry.
Measured: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Lung function
Patients will be asked to perform incentive spirometry which is a non-invasive assessment of the lung function. Spirometry (tidal breathing, forced vital capacity) and respiratory muscle strength will be recorded for all participants.
Measured: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Secondary outcomes (2)
Health-related Quality of Life in cancer patients
All participants will be asked to fill in a validated questionnaire, the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) for assessment of their current quality of life. The QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Items 1 to 28 have a four-point scale response, namely 'Not at all' (point 1), 'A little', 'Quite a bit' and 'Very much' (point 4). The last 2 items have a seven-point scale for assessment of the overall health and overall quality of life, being 'Very poor' (point 1) to 'Excellent (points 7). Higher scores in the function and global quality of life scales represent better levels outcome, whilst higher scores in symptom scales represent presence of more symptoms. Similarly, the EORTC QLQ-25 comprises of questionnaires to assess the quality of life. LASORS questionnaire assesses the long-term deficits in quality of life in this population.
Measured: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Health-related Quality of Life in patients with tumours of the oesophagus, oesophago-gastric junction or stomach
All participants will be asked to fill in a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Oesophago-Gastric Module 25 (EORTC QLQ-OG25) for assessment of their current quality of life. The QLQ-OG25 has six symptom scales (dysphagia, eating restrictions, reflux, odynophagia, pain and discomfort, and a scale assessing anxiety) and 10 single items relevant to patients undergoing palliative or potentially curative treatments and follow-up for upper gastrointestinal cancer. All items have four-point scale, namely 'Not at all' (point 1), 'A little', 'Quite a bit' and 'Very much' (point 4). Higher scores in symptom scales represent presence of more symptoms.
Measured: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start29 May 2019
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Why it stopped: Study closed before the planned recruitment target was reached because the study period ended before full recruitment could be completed. Recruitment ceased at study closure and data collection was completed for enrolled participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheraz R Markar, Dr, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835273
- Sponsor's protocol ID
- 19SM5007
- Status last verified
- Jul 2026
- First submitted
- 6 Feb 2019
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shirinzadeh A, Talebi Y. Pulmonary Complications due to Esophagectomy. J Cardiovasc Thorac Res. 2011;3(3):93-6. doi: 10.5681/jcvtr.2011.020. Epub 2011 Aug 20.
PubMed 24250962Nagawa H, Kobori O, Muto T. Prediction of pulmonary complications after transthoracic oesophagectomy. Br J Surg. 1994 Jun;81(6):860-2. doi: 10.1002/bjs.1800810622.
PubMed 8044603Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.
PubMed 22552194Kubo N, Ohira M, Yamashita Y, Sakurai K, Toyokawa T, Tanaka H, Muguruma K, Shibutani M, Yamazoe S, Kimura K, Nagahara H, Amano R, Ohtani H, Yashiro M, Maeda K, Hirakawa K. The impact of combined thoracoscopic and laparoscopic surgery on pulmonary complications after radical esophagectomy in patients with resectable esophageal cancer. Anticancer Res. 2014 May;34(5):2399-404.
PubMed 24778050Schmidt HM, El Lakis MA, Markar SR, Hubka M, Low DE. Accelerated Recovery Within Standardized Recovery Pathways After Esophagectomy: A Prospective Cohort Study Assessing the Effects of Early Discharge on Outcomes, Readmissions, Patient Satisfaction, and Costs. Ann Thorac Surg. 2016 Sep;102(3):931-939. doi: 10.1016/j.athoracsur.2016.04.005. Epub 2016 Jun 7.
PubMed 27283109Li C, Ferri LE, Mulder DS, Ncuti A, Neville A, Lee L, Kaneva P, Watson D, Vassiliou M, Carli F, Feldman LS. An enhanced recovery pathway decreases duration of stay after esophagectomy. Surgery. 2012 Oct;152(4):606-14; discussion 614-6. doi: 10.1016/j.surg.2012.07.021. Epub 2012 Sep 1.
PubMed 22943844Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PubMed 8433390Lagergren P, Fayers P, Conroy T, Stein HJ, Sezer O, Hardwick R, Hammerlid E, Bottomley A, Van Cutsem E, Blazeby JM; European Organisation for Research Treatment of Cancer Gastrointestinal and Quality of Life Groups. Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-OG25, to assess health-related quality of life in patients with cancer of the oesophagus, the oesophago-gastric junction and the stomach. Eur J Cancer. 2007 Sep;43(14):2066-73. doi: 10.1016/j.ejca.2007.07.005. Epub 2007 Aug 15.
PubMed 17702567
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Respiratory Function and Chest Wall Movement Following Oesophagectomy
- ClinicalTrials.gov ID
- NCT03835273
- Acronym / sponsor ID
- 19SM5007
- Conditions
- Esophageal Cancer, Esophagectomy, Respiratory Function Loss
- Keywords
- Esophagectomy, Motion capture, Respiratory, Oesophageal cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study closed before the planned recruitment target was reached because the study period ended before full recruitment could be completed. Recruitment ceased at study closure and data collection was completed for enrolled participants.
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open surgery for esophageal cancer commonly involves large incisions in the chest, associated with a high rate of pulmonary complications (30-50%). Minimally invasive approach through keyhole surgery has been shown to reduce pulmonary infections by 20%. Enhanced recovery programmes are evidence-based protocols, developed to achieve early recovery after surgery with early mobilisation and chest physiotherapy and have been shown to reduce pulmonary complication rates as well. The investigators intend to objectively measure chest wall movement using 3D motion capture system as well as a wearable measurement system to monitor chest wall movement.
Detailed description
The study population consists of 40 healthy volunteers who have not received upper gastrointestinal surgery and 60 patients treated with surgery more than one year ago (open approach). Chest wall movement will be measured using a 3D optical motion system and the investigators will establish if inertial measurement units placed strategically on the chest wall are able to quantify chest expansion and lung capacity. Data will be acquired during different breathing patterns and during use of an incentive spirometry. Pulmonary function tests will be undertaken in all patients and the investigators will also collect clinical data concerning health-related quality of life and other concomitant medical conditions. The target outcome of this study is to determine whether the 3D motion capture and wearable systems are reliable in the measurement of chest wall movement after surgical removal of esophagus and the validity and patient acceptability of wearable system, as well as the ability of distinguishing open and minimally invasive surgical approach. A tailored physiotherapy may be developed following this study in order to improve chest wall movement and objectively measure this using the wearable system. This can then be implemented in a clinical trial to provide the evidence base to for patient-tailored physiotherapy following major cancer surgery and to optimise the respiratory function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: 3D motion capture system, Other: Incentive spirometry, Other: QuestionnairesFourty control participants who have not received upper gastrointestinal surgery. |
| Open surgery | – | Other: 3D motion capture system, Other: Incentive spirometry, Other: QuestionnairesSixty patients who have undergone open removal of oesophagus more than one year ago. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Three cohorts will be studied, equal in size. A total of 100 patients will be included in this study. One hundred patients who have undergone oesophagectomy for oesophageal cancer more than a year ago, 60 patients who have undergone open surgery and 40 healthy volunteers will be included as a control group with no underlying respiratory disease and no previous history of upper gastrointestinal surgery. Patients who have undergone oesophagectomy will be identified from existing databases by the direct care team of the patient. Healthy volunteers will be recruited from Imperial College through paper adverts.
Key inclusion criteria (6 listed)
- Exposure group:
- Control group:
Key exclusion criteria (5 listed)
- Any participant who lacks capacity or is unable to provide informed consent.
- Any participant younger than 18 or older than 90 years of age.
- Any patient with evidence of cancer recurrence or on-going postoperative complication at more than one year following surgery for oesophageal cancer.
- Any pregnant participant.
- unable to or excluded from performing spirometry or respiratory muscle strength testing (non-invasive testing)
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 |
|---|---|---|
| 3D motion capture systemSmall reflective markers and inertia measurement units will be placed on the chest of the patients using hypoallergenic adhesive and a motion capture system will pick up a 3D image via these markers non-invasively. | Other | Control group, Open surgery |
| Incentive spirometryIncentive spirometry is a non-invasive device for assessment of pulmonary function. | Other | Control group, Open surgery |
| QuestionnairesThree validated, European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Oesophago-Gastric Module 25 (EORTC QLQ-OG25) and LASORS questionnaire. | Other | Control group, Open surgery |
Primary outcome
Chest wall movement
Time frame: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Evaluation of changes in chest wall movement in patients who have undergone oesophagectomy more than a year ago (open surgery) and in healthy control participants. Reflective markers will be placed on the chest wall of the participant and chest wall movement will be detected by a 3D motion capture system using these markers. In addition, inertia measurement units will be applied next to the markers. Chest wall movement will be assessed during normal breathing, take and hold a deep breath and whilst performing incentive spirometry.
Lung function
Time frame: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Patients will be asked to perform incentive spirometry which is a non-invasive assessment of the lung function. Spirometry (tidal breathing, forced vital capacity) and respiratory muscle strength will be recorded for all participants.
2 secondary outcomes
Health-related Quality of Life in cancer patients
Time frame: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Health-related Quality of Life in patients with tumours of the oesophagus, oesophago-gastric junction or stomach
Time frame: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Results and safety
The study was stopped early (reason given: Study closed before the planned recruitment target was reached because the study period ended before full recruitment could be completed. Recruitment ceased at study closure and data collection was completed for enrolled participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 24250962Shirinzadeh A, Talebi Y. Pulmonary Complications due to Esophagectomy. J Cardiovasc Thorac Res. 2011;3(3):93-6. doi: 10.5681/jcvtr.2011.020. Epub 2011 Aug 20.
- Background: PubMed 8044603Nagawa H, Kobori O, Muto T. Prediction of pulmonary complications after transthoracic oesophagectomy. Br J Surg. 1994 Jun;81(6):860-2. doi: 10.1002/bjs.1800810622.
- Background: PubMed 22552194Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.
- Background: PubMed 24778050Kubo N, Ohira M, Yamashita Y, Sakurai K, Toyokawa T, Tanaka H, Muguruma K, Shibutani M, Yamazoe S, Kimura K, Nagahara H, Amano R, Ohtani H, Yashiro M, Maeda K, Hirakawa K. The impact of combined thoracoscopic and laparoscopic surgery on pulmonary complications after radical esophagectomy in patients with resectable esophageal cancer. Anticancer Res. 2014 May;34(5):2399-404.
- Background: PubMed 27283109Schmidt HM, El Lakis MA, Markar SR, Hubka M, Low DE. Accelerated Recovery Within Standardized Recovery Pathways After Esophagectomy: A Prospective Cohort Study Assessing the Effects of Early Discharge on Outcomes, Readmissions, Patient Satisfaction, and Costs. Ann Thorac Surg. 2016 Sep;102(3):931-939. doi: 10.1016/j.athoracsur.2016.04.005. Epub 2016 Jun 7.
- Background: PubMed 22943844Li C, Ferri LE, Mulder DS, Ncuti A, Neville A, Lee L, Kaneva P, Watson D, Vassiliou M, Carli F, Feldman LS. An enhanced recovery pathway decreases duration of stay after esophagectomy. Surgery. 2012 Oct;152(4):606-14; discussion 614-6. doi: 10.1016/j.surg.2012.07.021. Epub 2012 Sep 1.
- Background: PubMed 8433390Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
- Background: PubMed 17702567Lagergren P, Fayers P, Conroy T, Stein HJ, Sezer O, Hardwick R, Hammerlid E, Bottomley A, Van Cutsem E, Blazeby JM; European Organisation for Research Treatment of Cancer Gastrointestinal and Quality of Life Groups. Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-OG25, to assess health-related quality of life in patients with cancer of the oesophagus, the oesophago-gastric junction and the stomach. Eur J Cancer. 2007 Sep;43(14):2066-73. doi: 10.1016/j.ejca.2007.07.005. Epub 2007 Aug 15.
- Individual participant dataSharing planned: No
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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.
Sheraz R Markar, Dr principal investigator
Imperial College London
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 Esophageal Cancer and Esophagectomy, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 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: stopped early, as of the sponsor's last update on 23 Jul 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 United Kingdom. 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 was stopped early (reason given: Study closed before the planned recruitment target was reached because the study period ended before full recruitment could be completed. Recruitment ceased at study closure and data collection was completed for enrolled participants.). Results are not available in the source record.
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?
Chest wall movement (time frame: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.). 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?
On the ClinicalTrials.gov record for NCT03835273, which also lists 8 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 Jul 2026.