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Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia

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ClinicalTrials.gov Identifier: NCT02875561
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
Stryker Instruments
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or ultrasonic aspiration.

Condition or disease Intervention/treatment Phase
Vulvar Intraepithelial Neoplasia (VIN) Device: Sonopet Ultrasonic Aspirator Device: CO2 Laser Ablation Not Applicable

Detailed Description:

Incidence of Vulvar Intraepithelial Neoplasia (VIN) is increasing among women and there still lacks a standard of care for optimal treatment. Current treatment options aim to treat the symptoms associated with VIN and result in a high recurrence rate. Due to the high reoccurrence rate and the nature of the current treatments, a more effective treatment option is warranted. An effective treatment that targets only the diseased areas could potentially decrease recurrence rates. Additionally, a more conservative treatment modality could contribute to reduced risks of scarring, discomfort, and psychosocial and sexual distraught. The researchers hypothesize that treatment for VIN with ultrasonic aspiration will have a 60% reduction in recurrence rates over 12 months as compared to CO2 laser aspiration.

This study will employ a randomized controlled trial (RCT) design. This is a phase III study to determine the effectiveness of a more targeted treatment therapy for VIN (comparing ultrasonic aspiration versus CO2 laser ablation). Potential participants will be identified through the gynecological clinical practices following diagnosis of high grade VIN and will be randomized (1:1) to one of the treatment therapies. Randomization will be stratified for multi-focal disease and Human Papillomavirus (HPV) status. Both the Sonopet Ultrasonic Aspirator and the CO2 laser ablation devices are FDA approved devices for the treatment of vulvar dysplasia.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
Actual Study Start Date : March 26, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sonopet Ultrasonic Aspirator
Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
Device: Sonopet Ultrasonic Aspirator
To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation

Experimental: CO2 Laser Ablation
Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
Device: CO2 Laser Ablation
To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation




Primary Outcome Measures :
  1. Incidence of recurrence of dysplasia [ Time Frame: 12 months ]
    Incidence of recurrence of dysplasia time point 12 months


Secondary Outcome Measures :
  1. Incidence of pain [ Time Frame: 10 days ]
    Pain will be evaluated by self-report through use of pain assessment scale.

  2. Incidence of scarring [ Time Frame: 6 weeks ]
    Physical evaluation for scarring

  3. Changes in Sexual Function [ Time Frame: Baseline (enrollment), 6 months, 12 months ]
    Evaluated by Female Sexual Function Index

  4. Changes in Mental and Physical Wellness [ Time Frame: Baseline (enrollment), 6 months, 12 months ]
    Evaluated by Functional Assessment of Cancer Therapy - Vulva (FACTS-V) health survey for vulva disease



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women 18-89 years old
  • Women diagnosed with high-grade VIN (diagnosed by pathology)
  • Women referred for vulva sparing treatment for dysplasia
  • Women available for follow-up of treatment for 12 months

Exclusion Criteria:

  • Women who are pregnant
  • Women with low-grade VIN dysplasia (diagnosed by pathology)
  • Women with vaginal intraepithelial neoplasia(VAIN)
  • Women requiring vulvectomy for treatment
  • Women unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875561


Contacts
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Contact: Dina Flink, PhD 303-724-8467 dina.flink@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Dina Flink, PhD    303-724-8467    dina.flink@ucdenver.edu   
Principal Investigator: Saketh Guntupalli, MD         
Sponsors and Collaborators
University of Colorado, Denver
Stryker Instruments
Investigators
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Principal Investigator: Saketh Guntupalli, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02875561     History of Changes
Other Study ID Numbers: 16-0701.cc
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Carcinoma in Situ
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type