An interventional study of Elira Investigational TENS device in Weight Loss, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-30.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Basic science
Among 15 studies in Weight Loss by Mayo Clinic — 1 open to participants now, 2 under way, none of them phase 3. Weight Loss · Mayo Clinic.
Among the 15 studies in Weight Loss by Mayo Clinic, this one is the 10th largest by enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2017, is one of 7 with no phase, and was the 9th registered.
1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.
Browse Weight Loss studies →1 of the 15 studies in Weight Loss by Mayo Clinic is open now, in 1 country. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
By country, each count listing its studies:
Of the 196 Weight Loss studies recruiting now, 71 (36%) set no upper age limit and 108 (55%) stop at 75 or younger; 21 take children under 18; 58 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 3 · Phase 4 1
First in 2012; this study’s year is marked. 2 started in 2017.
This study's enrollment of 16 is below the median of 80 across 1,561 interventional studies indexed under Weight Loss.
Median enrollment 46 across the 13 interventional studies, 19 across the 2 observational. Of the 13 that completed or were terminated, 8 (62%) have results posted.
This tab as a report to print or save as PDF → With an account.
Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
1 of the studies in Weight Loss by Mayo Clinic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03238794Mayo ClinicBariatric Surgery Versus Diet Alone in the Bile Acid Pathway and Weight Loss | 2027-01-11 |
Among the 15 studies in Weight Loss by Mayo Clinic, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The investigators are doing this research study to find out the effect of T6 Dermatomal Electrical Stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS) unit) on stomach motor activity.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During this TENS unit stimulation arm, subjects will have a narrow tube (about the diameter of a telephone cord) placed into the subjects small intestine by the study physician and trained technician. The technician will use a small amount of fluoroscopy (radiation) to make sure the tube is placed in the proper position. About one hour after the tube has been placed subjects will be given a breakfast meal. The narrow tube (GDM) will take pressure readings after being placed. After four hours, subjects will again be given a second meal. Fifteen minutes of electrical stimulation will be given to subjects fifteen minutes before ingestion of lunch. After ingestion of lunch, 60 minutes of the electrical stimulation will be applied. When the test is done, the tube will be removed.
Device: Elira Investigational TENS device
During this no TENS unit stimulation arm, subjects will have a narrow tube (about the diameter of a telephone cord) placed into the subjects small intestine by the study physician and trained technician. The technician will use a small amount of fluoroscopy (radiation) to make sure the tube is placed in the proper position. About one hour after the tube has been placed subjects will be given a breakfast meal. The narrow tube (GDM) will record stomach pressure readings after being placed. After four hours, subjects will again be given a second meal. The TENS unit stimulation will be placed but no electrical stimulation will be given. When the test is done, the tube will be removed.
Device: Elira Investigational TENS device
TENS unit placed on skin will deliver electric stimulation to abdominal area.
Also known as: Electric Stimulation from TENS unit
The Effect of T6 Dermatomal Electrical Stimulation on Subjects Stomach Motor Activity
Testing to see if dermatomal electrical stimulation will speed up or slow down the stomach motor activity.
Time frame: through study completion, an average of 1 year
| Milestone | Transcutaneous Electrical Nerve Stimulation (TENS) Stimulation | No TENS Stimulation |
|---|---|---|
| Started | 9 | 7 |
| Completed | 9 | 7 |
| Not completed | 0 | 0 |
Testing to see if dermatomal electrical stimulation will speed up or slow down the stomach motor activity.
No measurements were reported for this outcome.
Collected over Adverse Events were assessed through study completion, an average of 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TENS Unit Stimulation | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| No TENS Unit Stimulation | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | TENS Unit Stimulation | No TENS Unit Stimulation | Total |
|---|---|---|---|
| Mean | 40.1 ± 11.6 | 34 ± 7.9 | 36.6 ± 10.0 |
| Sex: Female, Male(Participants) | TENS Unit Stimulation | No TENS Unit Stimulation | Total |
|---|---|---|---|
| Female | 5 | 3 | 8 |
| Male | 4 | 4 | 8 |
| Race and Ethnicity Not Collected(Participants) | TENS Unit Stimulation | No TENS Unit Stimulation | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | TENS Unit Stimulation | No TENS Unit Stimulation | Total |
|---|---|---|---|
| United States | 9 | 7 | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2017 to primary completion in Jun 2018, 9 months.
Results were first posted in May 2019, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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