Needlefree Lidocaine Application for Vulvar Biopsies

NCT07793552 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00007018
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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).

  between the administration of the lidocaine to immediately after the biopsy

Secondary Outcomes (1)

• Patient nervousness, experience and acceptability, and provider acceptability

  before and after randomization, and the day after.

Study Arms (2)

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.

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.

Drug: Lidocaine HCl 1%

Interventions

J-Tip DEVICE

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.

J-Tip

Lidocaine HCl 1% DRUG

1-2ml of 1% lidocaine without epinephrine will be injected superficially using a 27-gauge needle

Standard Lidocaine Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2030
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)