Vulvar CancersNCT07793552
Needlefree Lidocaine Application for Vulvar Biopsies
A study testing J-Tip and Lidocaine HCl 1% in people with Vulvar Cancers and Vulva Neoplasm, run by Tufts Medical Center at 1 site in United States.
Trial summary
The goal of this study is to compare pain during a vulvar biopsy using either the needle-free J-Tip device or the standard lidocaine shot. We expect to enroll up to 106 subjects will be enrolled in this study at Tufts Medical Center. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvar Cancers, Vulva Neoplasm, Vulvar Dysplasia
- What is being tested?
- J-Tip and Lidocaine HCl 1%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People aged ≥18 years
- Planned to undergo a vulvar biopsy in a gynecologic outpatient office
- 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.
Who cannot join
- 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.
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Tufts Medical Center
Boston, Massachusetts, 02111
Afshin Azimirad, MD, 6176369561, aazimirad@tuftsmedicalcenter.org
About this study
Official title: Needlefree Lidocaine JTip Application for Pain Optimization in Vulvar Biopsies
The goal of this study is to compare pain during a vulvar biopsy using either the needle-free J-Tip device or the standard lidocaine shot. We expect to enroll up to 106 subjects will be enrolled in this study at Tufts Medical Center. The study will take place in a gynecology clinic or outpatient medical office where your biopsy is already scheduled. You will be asked to review and sign a consent form before joining the study. You will then complete a short survey about your background, pain level, and anxiety. During your visit, you will be randomly assigned (like flipping a coin) to receive numbing medicine either through a needle-free device (J-Tip) or a standard injection. The numbing medicine will be given before your vulvar biopsy. You will be asked to rate your pain and nervousness at different times at the beginning and after the procedure using a simple scale. After the biopsy, you will complete a short survey about your experience. Your doctor will also record details about the procedure. The day after your biopsy, you will be asked to complete one more short survey about your pain and overall experience.
- Conditions
- Vulvar Cancers, Vulva Neoplasm, Vulvar Dysplasia
- Being tested
- J-Tip, Lidocaine HCl 1%
- Medical subject headings
- Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J-TipDevice
Vulvar biopsies are routinely performed to diagnose dysplasia and cancer of the vulva. There is no pathognomonic appearance to vulvar intraepithelial neoplasia (VIN) and so any abnormal appearing vulvar lesion should be biopsied. HPV-related vulvar dysplasia is increasing, with 2.86 per 1000 females in 2000. There are 6500 cases of vulvar cancer annually.
ACOG has outlined the urgent need for health care professionals to better understand pain management options for patients. Higher levels of preprocedural anxiety or expectations of pain are associated with higher levels of patient-reported pain with office procedures. Users of social media platforms share patient experiences with gynecological procedures that were painful and traumatic, and woman are calling for better pain management for gynecological procedures. Participants receiving topical lidocaine prilocaine had less pain but there was still pain. An optimal anesthetic use and delivery has not been identified.
Lidocaine HCl 1%Drug
1-2ml of 1% lidocaine without epinephrine will be injected superficially using a 27-gauge needle
| Study group | Role | What they receive |
|---|---|---|
| J-Tip | Experimental | A baseline questionnaire including demographics and baseline pain and anxiety levels will be administered. Pain scores will be reported using the 100mm visual analog scale (VAS) where pain is rated on a scale from 0mm (no pain) to 100mm (worst pain). Pre-procedure nervousness will be measured in a similar fashion on a 100-mm VAS. Both will be measured at multiple time points during the procedure. Baseline anxiety will be measured using the validated Generalized Anxiety Disorder 7-item questionnaire. One administration of the J-Tip applicator filled with 1% lidocaine will be administered to the anticipated site of biopsy. A vulvar biopsy punch biopsy size of 3mm or 4mm will be utilized per standard of care. After the procedure and the following day, the patient will complete a brief questionnaire about the pain score, overall acceptability and tolerability. Receives: Device: J-Tip |
| Standard Lidocaine Injection | Active comparator | A baseline questionnaire including demographics and baseline pain and anxiety levels will be administered. Pain scores will be reported using the 100mm visual analog scale (VAS) where pain is rated on a scale from 0mm (no pain) to 100mm (worst pain). Pre-procedure nervousness will be measured in a similar fashion on a 100-mm VAS. Both will be measured at multiple time points during the procedure. Baseline anxiety will be measured using the validated Generalized Anxiety Disorder 7-item questionnaire. per standard of care, then 1-2ml of 1% lidocaine without epinephrine will be injected superficially using a 27-gauge needle. A vulvar biopsy punch biopsy size of 3mm or 4mm will be utilized per standard of care. After the procedure and the following day, the patient will complete a brief questionnaire about the pain score, overall acceptability and tolerability. Receives: Drug: Lidocaine HCl 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported pain
The primary outcome will be the highest patient reported pain score between the administration of the lidocaine to immediately after the biopsy. The 100mm visual analog scale will be utilized where pain is rated on a scale from 0mm (no pain) to 100mm (worst pain).
Measured: between the administration of the lidocaine to immediately after the biopsy
Secondary outcomes (1)
Patient nervousness, experience and acceptability, and provider acceptability
Pain score at biopsy, patient nervousness before and after randomization, patient experience and acceptability, and provider acceptability and perfection of patient tolerance, using the 100mm visual analog scale (VAS) where pain is rated on a scale from
Measured: before and after randomization, and the day after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar CancersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793552
- Sponsor's protocol ID
- STUDY00007018
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needlefree Lidocaine JTip Application for Pain Optimization in Vulvar Biopsies
- ClinicalTrials.gov ID
- NCT07793552
- Acronym / sponsor ID
- STUDY00007018
- Conditions
- Vulvar Cancers, Vulva Neoplasm, Vulvar Dysplasia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to compare pain during a vulvar biopsy using either the needle-free J-Tip device or the standard lidocaine shot. We expect to enroll up to 106 subjects will be enrolled in this study at Tufts Medical Center. The study will take place in a gynecology clinic or outpatient medical office where your biopsy is already scheduled. You will be asked to review and sign a consent form before joining the study. You will then complete a short survey about your background, pain level, and anxiety. During your visit, you will be randomly assigned (like flipping a coin) to receive numbing medicine either through a needle-free device (J-Tip) or a standard injection. The numbing medicine will be given before your vulvar biopsy. You will be asked to rate your pain and nervousness at different times at the beginning and after the procedure using a simple scale. After the biopsy, you will complete a short survey about your experience. Your doctor will also record details about the procedure. The day after your biopsy, you will be asked to complete one more short survey about your pain and overall experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| J-Tip | Experimental | Device: J-TipA baseline questionnaire including demographics and baseline pain and anxiety levels will be administered. Pain scores will be reported using the 100mm visual analog scale (VAS) where pain is rated on a scale from 0mm (no pain) to 100mm (worst pain). Pre-procedure nervousness will be measured in a similar fashion on a 100-mm VAS. Both will be measured at multiple time points during the procedure. Baseline anxiety will be measured using the validated Generalized Anxiety Disorder 7-item questionnaire. One administration of the J-Tip applicator filled with 1% lidocaine will be administered to the anticipated site of biopsy. A vulvar biopsy punch biopsy size of 3mm or 4mm will be utilized per standard of care. After the procedure and the following day, the patient will complete a brief questionnaire about the pain score, overall acceptability and tolerability. |
| Standard Lidocaine Injection | Active comparator | Drug: Lidocaine HCl 1%A baseline questionnaire including demographics and baseline pain and anxiety levels will be administered. Pain scores will be reported using the 100mm visual analog scale (VAS) where pain is rated on a scale from 0mm (no pain) to 100mm (worst pain). Pre-procedure nervousness will be measured in a similar fashion on a 100-mm VAS. Both will be measured at multiple time points during the procedure. Baseline anxiety will be measured using the validated Generalized Anxiety Disorder 7-item questionnaire. per standard of care, then 1-2ml of 1% lidocaine without epinephrine will be injected superficially using a 27-gauge needle. A vulvar biopsy punch biopsy size of 3mm or 4mm will be utilized per standard of care. After the procedure and the following day, the patient will complete a brief questionnaire about the pain score, overall acceptability and tolerability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- People aged ≥18 years
- Planned to undergo a vulvar biopsy in a gynecologic outpatient office
- 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.
Key exclusion criteria (2 listed)
- 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.
- Unable to provide informed consent.
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 |
|---|---|---|
| J-TipVulvar biopsies are routinely performed to diagnose dysplasia and cancer of the vulva. There is no pathognomonic appearance to vulvar intraepithelial neoplasia (VIN) and so any abnormal appearing vulvar lesion should be biopsied. HPV-related vulvar dysplasia is increasing, with 2.86 per 1000 females in 2000. There are 6500 cases of vulvar cancer annually. ACOG has outlined the urgent need for health care professionals to better understand pain management options for patients. Higher levels of preprocedural anxiety or expectations of pain are associated with higher levels of patient-reported pain with office procedures. Users of social media platforms share patient experiences with gynecological procedures that were painful and traumatic, and woman are calling for better pain management for gynecological procedures. Participants receiving topical lidocaine prilocaine had less pain but there was still pain. An optimal anesthetic use and delivery has not been identified. | Device | J-Tip |
| Lidocaine HCl 1%1-2ml of 1% lidocaine without epinephrine will be injected superficially using a 27-gauge needle | Drug | Standard Lidocaine Injection |
Primary outcome
Patient reported pain
Time frame: between the administration of the lidocaine to immediately after the biopsy
The primary outcome will be the highest patient reported pain score between the administration of the lidocaine to immediately after the biopsy. The 100mm visual analog scale will be utilized where pain is rated on a scale from 0mm (no pain) to 100mm (worst pain).
1 secondary outcome
Patient nervousness, experience and acceptability, and provider acceptability
Time frame: before and after randomization, and the day after.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing J-Tip and Lidocaine HCl 1% in people with Vulvar Cancers and Vulva Neoplasm, run by Tufts Medical Center 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 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: opening soon, as of the sponsor's last update on 28 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 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported pain (time frame: between the administration of the lidocaine to immediately after the biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2026.