Stenosis Cervix Clinical Trial
— DUDAOfficial title:
A Randomized Study to Evaluate the Safety, Efficacy and Quality of Life of a New Device to Prevent Cervical Stenosis After LEEP in High Grade Cervical Dysplasia
| Verified date | June 2018 |
| Source | Barretos Cancer Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Cervical stenosis may occur in up to 19% after conization. It is a cause of infertility and amenorrhea. This study will test a new device named DUDA Device ("Dispositivo Uterino para dilatar canal endocervical") placed just after the conization, in order to evaluate the safety, efficacy and quality of life.
| Status | Completed |
| Enrollment | 265 |
| Est. completion date | January 7, 2019 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - High Grade Cervical Dysplasia, Grades 2 and 3, in the biopsy cervical - Patient eligible for conization - Patient must consent for the appropriate surgery - Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1 - Patients must have signed an approved informed consent and authorization permitting release of personal health information Exclusion Criteria: - Pregnancy - Previous conization - limited comprehension of the study - the risk of the American Society of Anesthesiologists, III or IV - HIV or immunodepression - Patients with a history of the invasive malignancies |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Barretos Cancer Hospital | Barretos | São Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| Barretos Cancer Hospital |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety (two adverse events Grade 3 or 4 (CTCAE v. 4.0) or a single adverse event Grade 5) | The main safety events to be considered in this analysis are vaginal bleeding and uterine infection. The device is considered unsafe and consequently disrupted the study if a two adverse events Grade 3 or 4 (CTCAE v. 4.0) or a single adverse event Grade 5 related to the procedure/device happens during the phase 1. | 3 months | |
| Primary | Cervical stenosis | Stenosis of the endocervical canal (early and late) will be assessed by clinical information and physical examination at each visit to the hospital after surgery. The participant will be asked about the menstrual flow and dysmenorrhea during history taking. On physical examination, after the visualization of the cervix through the speculum examination, the doctor will check the channel permeability introducing a hysterometer through it. The difficulty of introducing the hysterometer 2.5mm the channel will be scored according to the following scale: Possible passage of hysterometer? () No difficulty () Little difficult, however possible passage of hysterometer () Unable to pass |
6 months | |
| Secondary | Pain Scales | The quality of life will be evaluated through questionnaires by the Functional Assessment of Cancer Therapy - Cervix Cancer (FACT-Cx) and the universal pain assessment tools that include international scale and pain visual analogue (EVA), numerical visual pain scale (EVN) and faces pain scales (EF). | 6 months | |
| Secondary | Complications | It will be evaluated during the following returns and described as any event related directly to the use of DUDA device as metrorrhagia and uterine infection. | 30 days | |
| Secondary | View of the squamo-columnar junction (SCJ) of the cervix | It will be assessed during the examination of colposcopy | 6 months |