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Could a tiny ear device replace opioids after cancer surgery?

NCT ID NCT05742711

Symptom relief Sponsor: DyAnsys, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a device that sends mild electrical pulses to the ear (called PENS) to see if it can reduce pain and the need for strong painkillers after surgery for endometrial or cervical cancer. 48 women who had open surgery took part. The goal was to find a safer, non-drug way to manage pain without the side effects of opioids.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Percutaneous Electrical Nerve Stimulator (PENS) device
What this could lead to
If it works, this could offer a non-drug way to manage pain after cancer surgery, reducing the need for opioids and their side effects.
What could go wrong
This is a small, completed trial with only 48 people. The device may not work better than a sham device, and results may not apply to all surgeries or cancers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

48 people

The number who actually took part.

Started

May 2023

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \>18 yrs * Diagnosed with CA-endometrium OR CA -cervix of stage I/II and post RT CA cervix patients coming for hysterectomy * Elective surgery * Informed consent obtained * ASA (American Society of Anaesthesiology) physical status 1-3 Exclusion Criteria: * Patient refusal * Cancer cervix other than the stages mentioned in inclusion criteria ASA PS \>3 * Emergency surgery, Laparoscopic and robotic procedures * Unplanned postoperative ventilation * Allergy/sensitivity to adhesive * Active skin infection/lesion in the ear region * H/O of seizure or cerebral disease * H/O chronic pain and prolonged analgesic usage * H/O opioid dependence * H/O anxiety or psychiatric illness requiring treatment * Pre-existing implantable/ electronic on demand device * Patients who might require MRI in the study period * Patients with transmissible diseases * Patients with coagulopathies * Absolute or relative contraindication to drugs used in the study

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Conditions

The condition(s) this trial relates to.

cervical carcinoma endometrial cancer endometrium neoplasm Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer of cervix Cancer of endometrium

Contacts and locations

Locations

  • Cancer Institute,(Wia)

    Chennai, Tamil Nadu, 600020, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.