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Can a Needle-Free device make vulvar biopsies less painful?

NCT ID NCT07793552

Symptom relief Sponsor: Tufts Medical Center 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial compares two ways of numbing the vulva before a biopsy: a needle-free device called the J-Tip and the standard lidocaine shot. About 106 adults scheduled for a vulvar biopsy will be randomly assigned to one of the two methods. Participants will rate their pain and nervousness before, during, and after the procedure, and answer surveys about their experience. The goal is to see if the needle-free approach reduces pain and improves comfort.

What this could mean

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

Active substance
Needle-free lidocaine delivery via the J-Tip device, compared with a standard lidocaine injection
What this could lead to
If it works, this could offer a less painful way to numb the vulva before biopsies, improving patient comfort and satisfaction.
What could go wrong
The trial is small and early, and the needle-free device may not numb as effectively as the standard shot. There is also a small risk of tissue damage, especially in people on chemotherapy.

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

About 106 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Accepted

You do not need to have the condition being studied to take part.

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: 1. People aged ≥18 years 2. Planned to undergo a vulvar biopsy in a gynecologic outpatient office 3. Individuals need to be able to provide informed consent. Consents will be available in English and interpretative services will be available in clinic visits to review the consent in other languages. Exclusion Criteria: 1. Patients actively receiving chemotherapeutic agents as this is a contraindication for J-Tip use due to concerns of increased incidence of tissue necrosis and bleeding. 2. Unable to provide informed consent.

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Conditions

The condition(s) this trial relates to.

vulva cancer vulvar neoplasm

As listed by the trial registrant

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

Vulva neoplasm Vulvar cancers Vulvar dysplasia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

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