An interventional study of J-Tip and Lidocaine HCl 1% in Vulvar Cancers, Vulva Neoplasm and Vulvar Dysplasia, sponsored by Tufts Medical Center. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Tufts Medical Center · Not applicable, Interventional, and Treatment
Among 107 studies in Vulvar Neoplasms with a site in United States — 20 open to participants now, 29 under way, none of them phase 3. Vulvar Neoplasms · United States.
Among the 107 studies in Vulvar Neoplasms with a site in United States, this one is the 18th largest by planned enrollment of the 80 interventional ones, is one of 5 that started in 2026, is one of 32 with no phase, reaches primary completion later than 25 of the 28 other live ones, and was the 107th registered.
236 studies on the registry are indexed under Vulvar Neoplasms; 69 are open to participants now.
This study's planned enrollment of 106 is above the median of 59 across 168 interventional studies indexed under Vulvar Neoplasms.
Browse Vulvar Neoplasms studies →20 of the 107 studies in Vulvar Neoplasms with a site in United States are open now, in 5 countries. Each count lists the studies.
Of the 53 Vulvar Neoplasms studies recruiting now, 39 (74%) set no upper age limit and 7 (13%) stop at 75 or younger; 4 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →107 studies; the count open now beside each. This study's row is marked.
First in 1992; this study’s year is marked. 5 started in 2026.
Median enrollment 46 across the 80 interventional studies, 148 across the 23 observational. Of the 69 that completed or were terminated, 16 (23%) have results posted.
11 of 107 have an industry lead sponsor. The 10 most frequent:
Tufts Medical Center is the lead sponsor of 200 studies on the registry; 28 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 16 (50%) have results posted.
Tufts Medical Center has 2 studies filed under Vulvar Neoplasms — fewer than ten, so there is no comparison to draw.
12 of the studies in Vulvar Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05979610University of UtahUsing Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies | 2026-12 |
| NCT05000294University of FloridaAtezolizumab Plus Tivozanib in Immunologically Cold Tumor Types | 2026-12 |
| NCT02993900Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsImage-Guided Gynecologic Brachytherapy | 2026-12 |
| NCT06677190Dana-Farber Cancer InstituteBelzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin | 2026-12-30 |
| NCT04169763M.D. Anderson Cancer CenterNelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery | 2026-12-31 |
Among the 107 studies in Vulvar Neoplasms with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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%
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.
1-2ml of 1% lidocaine without epinephrine will be injected superficially using a 27-gauge needle
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).
Time frame: between the administration of the lidocaine to immediately after the biopsy
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
Time frame: before and after randomization, and the day after.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.
Of 43 non-industry interventional studies with no phase under Vulvar Neoplasms, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 129. This study's planned 36 months is above that.
Counting every sponsor, half of 43 studies reached it within 28 months; a quarter within 17 and three quarters within 129.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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