Clinical trial · Interventional
Needlefree Lidocaine Application for Vulvar Biopsies
Needlefree Lidocaine JTip Application for Pain Optimization in Vulvar Biopsies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulva Neoplasm | Vulvar Neoplasm | ALIAS | 0.90 |
| Vulvar Cancers | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
| Vulvar Dysplasia | Vulvar Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| J-Tip | Device | — | UNRESOLVED |
| Lidocaine HCl 1% | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- J-Tip
- description
- 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.
- interventionNames
- Device: J-Tip
- type
- ACTIVE_COMPARATOR
- label
- Standard Lidocaine Injection
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available