GastroparesisNCT06411574
Body Surface Gastric Mapping vs Gastric Emptying Scintigraphy on Clinical Management in Gastroparesis
A study testing Gastric Alimetry in people with Gastroparesis, run by University of Western Sydney at 1 site in Australia.
Trial summary
Gastroparesis is a chronic and debilitating gastric disease associated with poor quality of life, psychological distress, frequent hospitalisations, and high healthcare utilization and associated costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Gastric Alimetry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 3 May 2024to 1 Nov 2025
- 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
- Aged over 18 years old
- Meeting Rome IV Criteria for Functional Dyspepsia and/or Chronic Nausea and Vomiting Syndrome
- Referred for gastric emptying scintigraphy
- Normal gastroscopy
- Negative or treated H. Pylori status
Who cannot join
- Pregnant or breast-feeding
- Inability to perform a BSGM test according to Indications for Use: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); unable to remain in a relaxed reclined position for the test duration.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Western Sydney University
Campbelltown, New South Wales, 2560
About this study
Official title: Comparing the Impact of Body Surface Gastric Mapping and Gastric Emptying Scintigraphy on Clinical Management in Suspected Gastroparesis
Gastroparesis is a chronic and debilitating gastric disease associated with poor quality of life, psychological distress, frequent hospitalisations, and high healthcare utilization and associated costs. It is defined by persistent upper gastrointestinal symptoms and delayed gastric emptying with no mechanical gastric outlet obstruction. Gastric emptying scintigraphy (GES) is the current gold standard for diagnosing gastroparesis but its clinical utility is currently being questioned. Current management strategies have often been found to be ineffective, largely due to an incomplete understanding of the disease's pathophysiology. There is a critical need for more advanced diagnostic testing that can better diagnose patients and guide personalized targeted therapy.
Body surface gastric mapping (BSGM) using Gastric Alimetry (Alimetry Ltd., New Zealand) is a new FDA-cleared medical device to assess gastric function by non-invasively assessing gastric motility using simultaneous high-resolution electrogastrography and symptom profiling. BSGM has demonstrated clinical utility in the assessment of gastric function through patient phenotyping in a variety of cohorts, including patients with nausea and vomiting disorders, diabetes, delayed gastric emptying, and post-gastric surgery. Previous research revealed that the detection of gastric motility abnormality rates through patient phenotyping were higher using Gastric Alimetry compared to GES (43% vs 23%). Clinical application of these phenotypes has also aided in changing management decisions, which reduced healthcare utilization and associated costs. However, how GES and BSGM test results differentially influence clinical management in patients is uncertain.
Read more
This exploratory pilot study proposes a two-arm, prospective trial to assess whether BSGM-guided care could change clinical outcomes compared to the standard of care (GES) in patients with suspected gastroparesis. The trial consists of two phases. Phase 1 involves participants separately undertaking a GES and BSGM test. Based on these results, the referring clinician will devise management plans for treatment using a standardized form: 1) unblinded to one test (GES or BSGM) but blinded to the other test; and 2) unblinded to both tests (GES + BSGM). They will be asked to recommend any changes to interventions (medications, diet, endoscopic/surgical referral or other) and additional testing. In phase 2, those in Phase 1 will undergo BSGM-guided care based on their combined management plan (GES + BSGM) and followed up over a 12 month period. A separate set of participants will be recruited to undergo standard of care (GES only) in parallel with Phase 1 participants. After 12 months, those on the standard of care arm will be crossed over to BSGM-guided care, undergo a BSGM test, treated according to the new management plan, and followed up over 6 months. Questionnaires will assess symptoms, quality of life, health psychology, sleep, and work impact.
If validated, this may change clinical practice by reducing the need for invasive or radioactive-based procedures to diagnose these patients and facilitating a more targeted treatment approach.
- Conditions
- Gastroparesis
- Being tested
- Gastric Alimetry
- Keywords
- Gastroparesis, Motility Disorders, Gastric Emptying Scintigraphy, Body Surface Gastric Mapping
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric AlimetryDevice
The Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Only the GES test result will be used to guide treatment as part of standard of care. |
| BSGM-guided care | Experimental | Both the GES and BSGM test results will be used to guide treatment. Receives: Device: Gastric Alimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Change in Clinical Management Decisions Based on the Combined Test Results Compared to the Single Test Result.
In phase 1, the change in clinical management decisions from the single test result to the combined test results was assessed. For each arm, the proportion of patients with a management change is reported as a percentage.
In the first plan (either unblinded to BSGM or GES first), a management change was defined as any addition, removal or modification within a category (eg, switching from 1 prokinetic to another) compared to the initial management plan.
In the second plan (unblinded to both test results), a change due to the combined test results was defined as any addition, removal or modification within the same category compared to the first plan.
The categories were: medication, diet, psychology-based interventions, surgery referral, other intervention and additional testing.
Measured: After unblinding to first test (week 1) and after unblinding to second test (week 2)
Secondary outcomes (2)
Phase 1: Change to a Single Clinical Diagnosis Due to the Combined Test Results From Baseline.
In phase 1, a change in diagnosis was defined as either an addition of a diagnosis or a shift to a different one compared to baseline (confirmation of an existing diagnosis was not considered a change).
Measured: After unblinding to first test (week 1) and after unblinding to second test (week 2)
Phase 1: Change in Clinician Certainty Based on the Combined Test Results Compared to a Single Test Result
In phase 1, Clinicians rated diagnostic and management plan certainty using a Likert scale (0-10; 0 = uncertain, 10 = certain) firstly after reviewing the initial allocated test (GES or BSGM) and formulating the first management plan with a single test result, and again after reviewing the second test and formulating the second management plan with the combined test results. The change in the certainty score from the single test result to the combined test results was assessed.
Measured: After unblinding to first test (week 1) and after unblinding to second test (week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start3 May 2024
- Primary completion30 Jan 2025
- Study completion1 Nov 2025
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 (8)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be recruited into one of two groups: standard of care (GES only) or BSGM-guided care (GES + BSGM). Each group will undergo treatment based on their respective management plan.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- University of Auckland, New Zealand
- Responsible party
- Principal investigator, Vincent Ho, University of Western Sydney
- Investigators
- Vincent Ho, MBBS, FRACP, FACP, PhD, Principal investigator, Western Sydney University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411574
- Sponsor's protocol ID
- WS-GMSC-001
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2024
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gharibans AA, Calder S, Varghese C, Waite S, Schamberg G, Daker C, Du P, Alighaleh S, Carson D, Woodhead J, Farrugia G, Windsor JA, Andrews CN, O'Grady G. Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device. Sci Transl Med. 2022 Sep 21;14(663):eabq3544. doi: 10.1126/scitranslmed.abq3544. Epub 2022 Sep 21.
PubMed 36130019Varghese C, Schamberg G, Calder S, Waite S, Carson D, Foong D, Wang WJ, Ho V, Woodhead J, Daker C, Xu W, Du P, Abell TL, Parkman HP, Tack J, Andrews CN, O'Grady G, Gharibans AA. Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis. Am J Gastroenterol. 2023 Jun 1;118(6):1047-1057. doi: 10.14309/ajg.0000000000002077. Epub 2022 Dec 20.
PubMed 36534985Wang WJ, Foong D, Calder S, Schamberg G, Varghese C, Tack J, Xu W, Daker C, Carson D, Waite S, Hayes T, Du P, Abell TL, Parkman HP, Huang IH, Fernandes V, Andrews CN, Gharibans AA, Ho V, O'Grady G. Gastric Alimetry Expands Patient Phenotyping in Gastroduodenal Disorders Compared with Gastric Emptying Scintigraphy. Am J Gastroenterol. 2024 Feb 1;119(2):331-341. doi: 10.14309/ajg.0000000000002528. Epub 2023 Oct 30.
PubMed 37782524Varghese C, Daker C, Lim A, Sebaratnam G, Xu W, Kean B, Cederwall C. Gastric Alimetry in the Management of Chronic Gastroduodenal Disorders: Impact to Diagnosis and Health Care Utilization. Clin Transl Gastroenterol. 2023 Nov 1;14(11):e00626. doi: 10.14309/ctg.0000000000000626.
PubMed 37589479Varghese C, Xu W, Daker C, Bissett IP, Cederwall C. Clinical utility of Gastric Alimetry® in the management of intestinal failure patients with possible underlying gut motility disorders. Clinical Nutrition Open Science [Internet]. 2023 Oct 1;51:15-25. Available from: https://www.sciencedirect.com/science/article/pii/S2667268523000359.
Xu W, Gharibans AA, Calder S, Schamberg G, Walters A, Jang J, Varghese C, Carson D, Daker C, Waite S, Andrews CN, Cundy T, O'Grady G. Defining and Phenotyping Gastric Abnormalities in Long-Term Type 1 Diabetes Using a Novel Body Surface Gastric Mapping Device. Gastro Hep Adv. 2023 Aug 18;2(8):1120-1132. doi: 10.1016/j.gastha.2023.08.005. eCollection 2023.
PubMed 39131562Xu W, Wang T, Foong D, Schamberg G, Evennett N, Beban G, Gharibans A, Calder S, Daker C, Ho V, O'Grady G. Characterization of gastric dysfunction after fundoplication using body surface gastric mapping. J Gastrointest Surg. 2024 Mar;28(3):236-245. doi: 10.1016/j.gassur.2023.12.023. Epub 2024 Jan 23.
PubMed 38445915Abraham R, Foong D, Ho V. Combined Gastric Alimetry and Gastric Emptying Scintigraphy Testing Increases Clinician Certainty in the Diagnosis and Management of Suspected Gastroparesis. J Neurogastroenterol Motil. 2026 Jan 30;32(1):61-70. doi: 10.5056/jnm25094. Epub 2025 Nov 20.
PubMed 41261563
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Impact of Body Surface Gastric Mapping and Gastric Emptying Scintigraphy on Clinical Management in Suspected Gastroparesis
- ClinicalTrials.gov ID
- NCT06411574
- Acronym / sponsor ID
- WS-GMSC-001
- Conditions
- Gastroparesis
- Keywords
- Gastroparesis, Motility Disorders, Gastric Emptying Scintigraphy, Body Surface Gastric Mapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Western SydneyUniversity, hospital or other
- Collaborators
- University of Auckland, New Zealand
- Study start
- 3 May 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastroparesis is a chronic and debilitating gastric disease associated with poor quality of life, psychological distress, frequent hospitalisations, and high healthcare utilization and associated costs. It is defined by persistent upper gastrointestinal symptoms and delayed gastric emptying with no mechanical gastric outlet obstruction. Gastric emptying scintigraphy (GES) is the current gold standard for diagnosing gastroparesis but its clinical utility is currently being questioned. Current management strategies have often been found to be ineffective, largely due to an incomplete understanding of the disease's pathophysiology. There is a critical need for more advanced diagnostic testing that can better diagnose patients and guide personalized targeted therapy.
Body surface gastric mapping (BSGM) using Gastric Alimetry (Alimetry Ltd., New Zealand) is a new FDA-cleared medical device to assess gastric function by non-invasively assessing gastric motility using simultaneous high-resolution electrogastrography and symptom profiling. BSGM has demonstrated clinical utility in the assessment of gastric function through patient phenotyping in a variety of cohorts, including patients with nausea and vomiting disorders, diabetes, delayed gastric emptying, and post-gastric surgery. Previous research revealed that the detection of gastric motility abnormality rates through patient phenotyping were higher using Gastric Alimetry compared to GES (43% vs 23%). Clinical application of these phenotypes has also aided in changing management decisions, which reduced healthcare utilization and associated costs. However, how GES and BSGM test results differentially influence clinical management in patients is uncertain.
This exploratory pilot study proposes a two-arm, prospective trial to assess whether BSGM-guided care could change clinical outcomes compared to the standard of care (GES) in patients with suspected gastroparesis. The trial consists of two phases. Phase 1 involves participants separately undertaking a GES and BSGM test. Based on these results, the referring clinician will devise management plans for treatment using a standardized form: 1) unblinded to one test (GES or BSGM) but blinded to the other test; and 2) unblinded to both tests (GES + BSGM). They will be asked to recommend any changes to interventions (medications, diet, endoscopic/surgical referral or other) and additional testing. In phase 2, those in Phase 1 will undergo BSGM-guided care based on their combined management plan (GES + BSGM) and followed up over a 12 month period. A separate set of participants will be recruited to undergo standard of care (GES only) in parallel with Phase 1 participants. After 12 months, those on the standard of care arm will be crossed over to BSGM-guided care, undergo a BSGM test, treated according to the new management plan, and followed up over 6 months. Questionnaires will assess symptoms, quality of life, health psychology, sleep, and work impact.
If validated, this may change clinical practice by reducing the need for invasive or radioactive-based procedures to diagnose these patients and facilitating a more targeted treatment approach.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be recruited into one of two groups: standard of care (GES only) or BSGM-guided care (GES + BSGM). Each group will undergo treatment based on their respective management plan.
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Only the GES test result will be used to guide treatment as part of standard of care. |
| BSGM-guided care | Experimental | Device: Gastric AlimetryBoth the GES and BSGM test results will be used to guide treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged over 18 years old
- Meeting Rome IV Criteria for Functional Dyspepsia and/or Chronic Nausea and Vomiting Syndrome
- Referred for gastric emptying scintigraphy
- Normal gastroscopy
- Negative or treated H. Pylori status
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding
- Inability to perform a BSGM test according to Indications for Use: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); unable to remain in a relaxed reclined position for the test duration.
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 |
|---|---|---|
| Gastric AlimetryThe Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders. | Device | BSGM-guided care |
Primary outcome
Phase 1: Change in Clinical Management Decisions Based on the Combined Test Results Compared to the Single Test Result.
Time frame: After unblinding to first test (week 1) and after unblinding to second test (week 2)
In phase 1, the change in clinical management decisions from the single test result to the combined test results was assessed. For each arm, the proportion of patients with a management change is reported as a percentage. In the first plan (either unblinded to BSGM or GES first), a management change was defined as any addition, removal or modification within a category (eg, switching from 1 prokinetic to another) compared to the initial management plan. In the second plan (unblinded to both test results), a change due to the combined test results was defined as any addition, removal or modification within the same category compared to the first plan. The categories were: medication, diet, psychology-based interventions, surgery referral, other intervention and additional testing.
2 secondary outcomes
Phase 1: Change to a Single Clinical Diagnosis Due to the Combined Test Results From Baseline.
Time frame: After unblinding to first test (week 1) and after unblinding to second test (week 2)
Phase 1: Change in Clinician Certainty Based on the Combined Test Results Compared to a Single Test Result
Time frame: After unblinding to first test (week 1) and after unblinding to second test (week 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36130019Gharibans AA, Calder S, Varghese C, Waite S, Schamberg G, Daker C, Du P, Alighaleh S, Carson D, Woodhead J, Farrugia G, Windsor JA, Andrews CN, O'Grady G. Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device. Sci Transl Med. 2022 Sep 21;14(663):eabq3544. doi: 10.1126/scitranslmed.abq3544. Epub 2022 Sep 21.
- Background: PubMed 36534985Varghese C, Schamberg G, Calder S, Waite S, Carson D, Foong D, Wang WJ, Ho V, Woodhead J, Daker C, Xu W, Du P, Abell TL, Parkman HP, Tack J, Andrews CN, O'Grady G, Gharibans AA. Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis. Am J Gastroenterol. 2023 Jun 1;118(6):1047-1057. doi: 10.14309/ajg.0000000000002077. Epub 2022 Dec 20.
- Background: PubMed 37782524Wang WJ, Foong D, Calder S, Schamberg G, Varghese C, Tack J, Xu W, Daker C, Carson D, Waite S, Hayes T, Du P, Abell TL, Parkman HP, Huang IH, Fernandes V, Andrews CN, Gharibans AA, Ho V, O'Grady G. Gastric Alimetry Expands Patient Phenotyping in Gastroduodenal Disorders Compared with Gastric Emptying Scintigraphy. Am J Gastroenterol. 2024 Feb 1;119(2):331-341. doi: 10.14309/ajg.0000000000002528. Epub 2023 Oct 30.
- Background: PubMed 37589479Varghese C, Daker C, Lim A, Sebaratnam G, Xu W, Kean B, Cederwall C. Gastric Alimetry in the Management of Chronic Gastroduodenal Disorders: Impact to Diagnosis and Health Care Utilization. Clin Transl Gastroenterol. 2023 Nov 1;14(11):e00626. doi: 10.14309/ctg.0000000000000626.
- BackgroundVarghese C, Xu W, Daker C, Bissett IP, Cederwall C. Clinical utility of Gastric Alimetry® in the management of intestinal failure patients with possible underlying gut motility disorders. Clinical Nutrition Open Science [Internet]. 2023 Oct 1;51:15-25. Available from: https://www.sciencedirect.com/science/article/pii/S2667268523000359.
- Background: PubMed 39131562Xu W, Gharibans AA, Calder S, Schamberg G, Walters A, Jang J, Varghese C, Carson D, Daker C, Waite S, Andrews CN, Cundy T, O'Grady G. Defining and Phenotyping Gastric Abnormalities in Long-Term Type 1 Diabetes Using a Novel Body Surface Gastric Mapping Device. Gastro Hep Adv. 2023 Aug 18;2(8):1120-1132. doi: 10.1016/j.gastha.2023.08.005. eCollection 2023.
- Background: PubMed 38445915Xu W, Wang T, Foong D, Schamberg G, Evennett N, Beban G, Gharibans A, Calder S, Daker C, Ho V, O'Grady G. Characterization of gastric dysfunction after fundoplication using body surface gastric mapping. J Gastrointest Surg. 2024 Mar;28(3):236-245. doi: 10.1016/j.gassur.2023.12.023. Epub 2024 Jan 23.
- Results publication: PubMed 41261563Abraham R, Foong D, Ho V. Combined Gastric Alimetry and Gastric Emptying Scintigraphy Testing Increases Clinician Certainty in the Diagnosis and Management of Suspected Gastroparesis. J Neurogastroenterol Motil. 2026 Jan 30;32(1):61-70. doi: 10.5056/jnm25094. Epub 2025 Nov 20.
- Individual participant dataSharing planned: No
Related trials for Gastroparesis
Recruiting
Gastric Focused Ultrasound Stimulation
Gastroparesis, Delayed Gastric Emptying
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
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.
Vincent Ho, MBBS, FRACP, FACP, PhD principal investigator
Western Sydney University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Alimetry in people with Gastroparesis, run by University of Western Sydney at 1 site in Australia.
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 5 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 31 Aug 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 Australia. 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 31 Aug 2026). 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?
Phase 1: Change in Clinical Management Decisions Based on the Combined Test Results Compared to the Single Test Result. (time frame: After unblinding to first test (week 1) and after unblinding to second test (week 2)). 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 NCT06411574, 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 31 Aug 2026.