Gastroparesis With Diabetes MellitusNCT05362578
Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis
A study testing transcutaneous electrical accustimulation at treatment point. in people with Gastroparesis With Diabetes Mellitus, run by University of Michigan at 1 site in United States.
Trial summary
The device being studied, the Transcutaneous Electrical Accustimulator (TEA), will deliver weak electrical current at two specific points, one at the leg and the other at the arm at settings known to improve symptoms involving the digestive system. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroparesis With Diabetes Mellitus
- What is being tested?
- transcutaneous electrical accustimulation at treatment point.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2022to 28 Feb 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least a 3-month history of diabetic gastroparesis symptoms on an on-going basis; at least one severe gastroparetic symptom or two moderate gastroparetic symptoms (e.g. vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain) during the screening.
- Documented delayed gastric emptying within past 3 years
- Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to the experiment (daily adjustments of insulin doses are permitted if patient has diabetes)
Who cannot join
- Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube
- History of gastric surgery such as fundoplication, gastrectomy, or vagotomy
- Symptoms suggestive of gastroparesis with no diagnosis of diabetes
- Pregnancy or expect to conceive during the course of the study
- Uncontrolled diabetes mellitus (HbA1c > 11%).
- Having any implanted medical device, such as cardiac pacemaker or Entera device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wearable Transcutaneous Electrical Acustimulation for Gastroparesis
The device being studied, the Transcutaneous Electrical Accustimulator (TEA), will deliver weak electrical current at two specific points, one at the leg and the other at the arm at settings known to improve symptoms involving the digestive system. The study team would like to test if the device will impact the gastrointestinal (GI) symptoms and gastric motility in study participants with gastroparesis.
Read the detailed description
This study aims to assess if the device will impact the (GI) symptoms and gastric motility in study participants with gastroparesis. This will be done over a 12 week period during which each participant will undergo two visits. There will be two total visits that each follow the same schedule. During the first visit, subjects will undergo a 3-in-1 gastric functional test which is a non-invasive method to assess the gastric motility and visceral pain. This test will entail an EGG, ECG, and water satiety drink test for gastric accommodation. Following the 3-in-1 gastric functional test, subjects will be randomized and trained on how to use the study device. Half of the patients will be assigned to the sham group and half will be assigned to the treatment group. Each group will undergo 8 weeks of treatment or 8 weeks of sham stimulation and will receive weekly calls from the study team to check for adverse events and study compliance. Following the first 8 week period, subjects will return to the study site to undergo visit two. This will follow the same format as visit 1. At this time, subjects will become unblinded. Those who received sham stimulation will be trained on the correct locations for each TEA device and will receive an additional 4 weeks of treatment with the device.
Note: The gastric emptying breathalyzer test (GEBT) was removed, and the two-day visits were shortened to one-day to improve patient recruitment and retention.
- Conditions
- Gastroparesis With Diabetes Mellitus
- Being tested
- transcutaneous electrical accustimulation at treatment point., transcutaneous electrical accustimulation at sham point.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical accustimulation at treatment point.Device
The transcutaneous electrical accustimulator (TEA) device administers a mild electrical shock through the skin, similar to acupuncture at a location previously seen to provide benefit. The precise distinction between sham and experimental accustimulation is not described upon registration to reduce unblinding risk, to maintain scientific integrity.
transcutaneous electrical accustimulation at sham point.Device
The transcutaneous electrical accustimulator (TEA) device administers a mild electrical shock through the skin, similar to acupuncture at a location which has not been shown to provide benefit. The precise distinction between sham and experimental accustimulation is not described upon registration to reduce unblinding risk, to maintain scientific integrity.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Subjects will be trained to use the devices at the treatment points and will undergo the treatment twice per day for 8 weeks. Following the first 8 weeks, at visit two, the devices will be collected by the study team. Receives: Device: transcutaneous electrical accustimulation at treatment point. |
| Sham group | Sham comparator | Subjects will be trained to use the devices at sham points and will undergo sham stimulation for the first 8 weeks. At visit two, after unmasking, subjects will optionally be trained on the treatment points and may participate in treatment for 4 weeks. Receives: Device: transcutaneous electrical accustimulation at sham point. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD) symptom daily score was generated by summing the scores on each of five symptom items (nausea, early satiety, postprandial fullness, upper abdominal pain, and number of vomiting episodes), each ranging from 0 (none) to 4 (very severe) and then dividing by 5, that is the number of items within the gastroparesis related symptom score. The minimum score was 0 and the maximum score was 4. Higher numbers indicated greater symptom impact.
Scores will be compared from day 0 to day 84.
Measured: Up to 84 days
Secondary outcomes (6)
36-Item Short Form Survey Instrument (SF-36) to Measure Quality of Life (QOL)
A 36-question assessment to score overall quality of life. The SF-36 consisted of eight health domains with questions, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0-100 scale on the assumption that each question carried equal weight. The scores from those domains were then averaged together for a final score within a full range of 0-100, with higher values indicating greater function and 100 representing the highest level of functioning possible.
Measured: 8 weeks
Gastric Accommodation
A water-satiety drink test was performed during which the participant was asked to drink at a speed of 60ml/min until reaching the maximum tolerable volume (MTV). Results reflect the maximum tolerable volume of the water-satiety drinking test.
Measured: 8 weeks
Electrogastrogram (EGG)
EGG was performed twice at both the baseline and at the 8-week visit. One 30-minute EGG was performed prior to the gastric accommodation test, and one 30-minute EGG was performed after the nutrient drink test. The goal was to measure gastric slow waves, which act as an indirect measure of gastric transit time. The difference in slow waves was compared pre- and post- gastric accommodation. Slow waves were also compared between visit 1 and visit 2. The percentage of normal gastric slow waves was previously used to predict delayed gastric emptying in participants with gastroparesis. Higher percentage of normal slow waves suggests an improvement in gastric emptying.
Measured: Visit 1 and visit 2 at 8 weeks
Electrocardiogram (ECG) - High-frequency Power (HFn)
ECG recorded while sitting 30 minutes b/f drinking (fasting) and 30 minutes after drinking water. Same procedure used at first visit (pretreatment) and second visit (post-treatment week 8). Goal was to measure autonomic function by calculating heart rate variability (HRV). Artifacts from recoded ECG signal were removed and R-peaks were detected. Time interval b/w successive R-peaks (RR interval) was calculated to generate HRV signal, which was used to calculate HRV parameters. Power w/i 0.15-0.40 Hz frequency band was defined as high-frequency (HF) power, while power w/i 0.04-0.15 Hz band was defined as low-frequency (LF) power. Normalized high-frequency power (HFn) was calculated as HFn = HF/HF+LF. HFn showed vagal/parasympathetic activity, with higher values indicating more active parasympathetic response and more responsive autonomic system. Pre-drinking (fasting) value of each HRV parameter at baseline (week 0) was compared to week 8 (after treatment) for both TEA and Sham groups.
Measured: 8 weeks
Electrocardiogram (ECG) - Sympathetic Index (SI)
The ECG was recorded in sitting position for 30 minutes before drinking (under fasting state) and 30 minutes after drinking water in sitting position. The same procedure was followed during first visit (pretreatment) and during the second visit (post-treatment week 8). The goal is to measure autonomic function via calculating the heart rate variability (HRV). The artifacts from the recoded ECG signal were removed and R-peaks were detected. The time interval between successive R peaks (the RR interval) was calculated to generate the HRV signal, which was used to calculate the HRV parameters. Sympathetic Index (SI) is HRV marker of Sympathetic Nervous system activity, with lower number meaning lower sympathetic activity and high numbers indicating greater sympathetic activity. The pre-drinking (fasting) value of each HRV parameter at baseline (week 0) was compared to that at week 8 (after treatment) for both TEA and Sham groups.
Measured: 8 weeks
Electrocardiogram (ECG) - LFn/HFn Ratio
The ECG was recorded in sitting position for 30 minutes before drinking (under fasting state) and 30 minutes after drinking water in sitting position. The same procedure was followed during first visit (pretreatment) and during the second visit (post-treatment week 8). The goal was to measure autonomic function via calculating the heart rate variability (HRV). The artifacts from the recoded ECG signal were removed and R-peaks were detected. The time interval between successive R peaks (the RR interval) was calculated to generate the HRV signal, which was used to calculate the HRV parameters. The LFn/HFn ratio reflects autonomic balance, with higher value indicating the autonomic balance shifts towards the sympathetic, which a lower value indicates that the autonomic balance shifts towards the parasympathetic. The pre-drinking (fasting) value of each HRV parameter at baseline (week 0) was compared to that at week 8 (after treatment) for both TEA and Sham groups.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start8 Sep 2022
- Primary completion28 Feb 2025
- Study completion28 Feb 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 (5)Papers the sponsor has linked to this study.
- Other trials for Gastroparesis With Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Borko Nojkov, University of Michigan
- Investigators
- Borko Nojkov, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362578
- Sponsor's protocol ID
- HUM00204800
- Other IDs
- 5R44AT011380-02
- Status last verified
- May 2026
- First submitted
- 31 Mar 2022
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified individual participant data will not be shared. However, the study protocol and the study results will be shared
Publications
Ma D, Han JS, Diao QH, Deng GF, Ping XJ, Jin WJ, Wu LZ, Cui CL, Li XD. Transcutaneous electrical acupoint stimulation for the treatment of withdrawal syndrome in heroin addicts. Pain Med. 2015 May;16(5):839-48. doi: 10.1111/pme.12738.
PubMed 25989154Jiang Y, Liu J, Liu J, Han J, Wang X, Cui C. Cerebral blood flow-based evidence for mechanisms of low- versus high-frequency transcutaneous electric acupoint stimulation analgesia: a perfusion fMRI study in humans. Neuroscience. 2014 May 30;268:180-93. doi: 10.1016/j.neuroscience.2014.03.019. Epub 2014 Mar 20.
PubMed 24657460Qu F, Wang FF, Wu Y, Zhou J, Robinson N, Hardiman PJ, Pan JX, He YJ, Zhu YH, Wang HZ, Ye XQ, He KL, Cui L, Zhao HL, Ye YH. Transcutaneous Electrical Acupoint Stimulation Improves the Outcomes of In Vitro Fertilization: A Prospective, Randomized and Controlled Study. Explore (NY). 2017 Sep-Oct;13(5):306-312. doi: 10.1016/j.explore.2017.06.004. Epub 2017 Jun 30.
PubMed 28915981Yu Y, Wei R, Liu Z, Xu J, Xu C, Chen JDZ. Ameliorating Effects of Transcutaneous Electrical Acustimulation Combined With Deep Breathing Training on Refractory Gastroesophageal Reflux Disease Mediated via the Autonomic Pathway. Neuromodulation. 2019 Aug;22(6):751-757. doi: 10.1111/ner.13021. Epub 2019 Jul 26.
PubMed 31347247Zhang B, Xu F, Hu P, Zhang M, Tong K, Ma G, Xu Y, Zhu L, Chen JDZ. Needleless Transcutaneous Electrical Acustimulation: A Pilot Study Evaluating Improvement in Post-Operative Recovery. Am J Gastroenterol. 2018 Jul;113(7):1026-1035. doi: 10.1038/s41395-018-0156-y. Epub 2018 Jun 21.
PubMed 29925916
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Transcutaneous Electrical Acustimulation for Gastroparesis
- ClinicalTrials.gov ID
- NCT05362578
- Acronym / sponsor ID
- HUM00204800
- Conditions
- Gastroparesis With Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Posted 20 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The device being studied, the Transcutaneous Electrical Accustimulator (TEA), will deliver weak electrical current at two specific points, one at the leg and the other at the arm at settings known to improve symptoms involving the digestive system. The study team would like to test if the device will impact the gastrointestinal (GI) symptoms and gastric motility in study participants with gastroparesis.
Detailed description
This study aims to assess if the device will impact the (GI) symptoms and gastric motility in study participants with gastroparesis. This will be done over a 12 week period during which each participant will undergo two visits. There will be two total visits that each follow the same schedule. During the first visit, subjects will undergo a 3-in-1 gastric functional test which is a non-invasive method to assess the gastric motility and visceral pain. This test will entail an EGG, ECG, and water satiety drink test for gastric accommodation. Following the 3-in-1 gastric functional test, subjects will be randomized and trained on how to use the study device. Half of the patients will be assigned to the sham group and half will be assigned to the treatment group. Each group will undergo 8 weeks of treatment or 8 weeks of sham stimulation and will receive weekly calls from the study team to check for adverse events and study compliance. Following the first 8 week period, subjects will return to the study site to undergo visit two. This will follow the same format as visit 1. At this time, subjects will become unblinded. Those who received sham stimulation will be trained on the correct locations for each TEA device and will receive an additional 4 weeks of treatment with the device.
Note: The gastric emptying breathalyzer test (GEBT) was removed, and the two-day visits were shortened to one-day to improve patient recruitment and retention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: transcutaneous electrical accustimulation at treatment point.Subjects will be trained to use the devices at the treatment points and will undergo the treatment twice per day for 8 weeks. Following the first 8 weeks, at visit two, the devices will be collected by the study team. |
| Sham group | Sham comparator | Device: transcutaneous electrical accustimulation at sham point.Subjects will be trained to use the devices at sham points and will undergo sham stimulation for the first 8 weeks. At visit two, after unmasking, subjects will optionally be trained on the treatment points and may participate in treatment for 4 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least a 3-month history of diabetic gastroparesis symptoms on an on-going basis; at least one severe gastroparetic symptom or two moderate gastroparetic symptoms (e.g. vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain) during the screening.
- Documented delayed gastric emptying within past 3 years
- Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to the experiment (daily adjustments of insulin doses are permitted if patient has diabetes)
Key exclusion criteria (6 listed)
- Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube
- History of gastric surgery such as fundoplication, gastrectomy, or vagotomy
- Symptoms suggestive of gastroparesis with no diagnosis of diabetes
- Pregnancy or expect to conceive during the course of the study
- Uncontrolled diabetes mellitus (HbA1c > 11%).
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 |
|---|---|---|
| transcutaneous electrical accustimulation at treatment point.The transcutaneous electrical accustimulator (TEA) device administers a mild electrical shock through the skin, similar to acupuncture at a location previously seen to provide benefit. The precise distinction between sham and experimental accustimulation is not described upon registration to reduce unblinding risk, to maintain scientific integrity. | Device | Treatment group |
| transcutaneous electrical accustimulation at sham point.The transcutaneous electrical accustimulator (TEA) device administers a mild electrical shock through the skin, similar to acupuncture at a location which has not been shown to provide benefit. The precise distinction between sham and experimental accustimulation is not described upon registration to reduce unblinding risk, to maintain scientific integrity. | Device | Sham group |
Primary outcome
Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
Time frame: Up to 84 days
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD) symptom daily score was generated by summing the scores on each of five symptom items (nausea, early satiety, postprandial fullness, upper abdominal pain, and number of vomiting episodes), each ranging from 0 (none) to 4 (very severe) and then dividing by 5, that is the number of items within the gastroparesis related symptom score. The minimum score was 0 and the maximum score was 4. Higher numbers indicated greater symptom impact. Scores will be compared from day 0 to day 84.
6 secondary outcomes
36-Item Short Form Survey Instrument (SF-36) to Measure Quality of Life (QOL)
Time frame: 8 weeks
Gastric Accommodation
Time frame: 8 weeks
Electrogastrogram (EGG)
Time frame: Visit 1 and visit 2 at 8 weeks
Electrocardiogram (ECG) - High-frequency Power (HFn)
Time frame: 8 weeks
Electrocardiogram (ECG) - Sympathetic Index (SI)
Time frame: 8 weeks
Electrocardiogram (ECG) - LFn/HFn Ratio
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25989154Ma D, Han JS, Diao QH, Deng GF, Ping XJ, Jin WJ, Wu LZ, Cui CL, Li XD. Transcutaneous electrical acupoint stimulation for the treatment of withdrawal syndrome in heroin addicts. Pain Med. 2015 May;16(5):839-48. doi: 10.1111/pme.12738.
- Background: PubMed 24657460Jiang Y, Liu J, Liu J, Han J, Wang X, Cui C. Cerebral blood flow-based evidence for mechanisms of low- versus high-frequency transcutaneous electric acupoint stimulation analgesia: a perfusion fMRI study in humans. Neuroscience. 2014 May 30;268:180-93. doi: 10.1016/j.neuroscience.2014.03.019. Epub 2014 Mar 20.
- Background: PubMed 28915981Qu F, Wang FF, Wu Y, Zhou J, Robinson N, Hardiman PJ, Pan JX, He YJ, Zhu YH, Wang HZ, Ye XQ, He KL, Cui L, Zhao HL, Ye YH. Transcutaneous Electrical Acupoint Stimulation Improves the Outcomes of In Vitro Fertilization: A Prospective, Randomized and Controlled Study. Explore (NY). 2017 Sep-Oct;13(5):306-312. doi: 10.1016/j.explore.2017.06.004. Epub 2017 Jun 30.
- Background: PubMed 31347247Yu Y, Wei R, Liu Z, Xu J, Xu C, Chen JDZ. Ameliorating Effects of Transcutaneous Electrical Acustimulation Combined With Deep Breathing Training on Refractory Gastroesophageal Reflux Disease Mediated via the Autonomic Pathway. Neuromodulation. 2019 Aug;22(6):751-757. doi: 10.1111/ner.13021. Epub 2019 Jul 26.
- Background: PubMed 29925916Zhang B, Xu F, Hu P, Zhang M, Tong K, Ma G, Xu Y, Zhu L, Chen JDZ. Needleless Transcutaneous Electrical Acustimulation: A Pilot Study Evaluating Improvement in Post-Operative Recovery. Am J Gastroenterol. 2018 Jul;113(7):1026-1035. doi: 10.1038/s41395-018-0156-y. Epub 2018 Jun 21.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be shared. However, the study protocol and the study results will be shared
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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.
Borko Nojkov, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical accustimulation at treatment point. in people with Gastroparesis With Diabetes Mellitus, run by University of Michigan at 1 site in United States.
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 3 inclusion and 6 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 20 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 States. 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. Some participants in this study may receive a placebo. 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 20 Jul 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?
Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD) (time frame: Up to 84 days). 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 NCT05362578, which also lists 5 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 20 Jul 2026.