Stenosis CervixDUDANCT02500966
How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia?
A study testing DUDA device and LEEP in people with Stenosis Cervix, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Stenosis Cervix
- What is being tested?
- DUDA device and LEEP
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to 7 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
This device has the potential to improve outcomes by means of a significant stenosis reduction and maintain patency of the endocervical canal to view the squamo-columnar junction (SCJ) of the cervix during follow-up of this patient.
- Conditions
- Stenosis Cervix
- Being tested
- DUDA device, LEEP
- Keywords
- Cervical Intraepithelial Neoplasia, stenosis, cervix, medical device, inventories, Uterine Cervix, Intrauterine Devices, intrauterine, conization, loop electrosurgical excision
- Medical subject headings
- Uterine Cervical Dysplasia, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DUDA deviceDevice
Insertion DUDA device
LEEPProcedure or surgery
Loop Electrosurgical Excision Procedure
| Study group | Role | What they receive |
|---|---|---|
| DUDA device | Experimental | The number of patients to be recruited in this arm will be 145. Note: The first twenty-five patients who will be included in the study will be allocated in the intervention arm to safety analysis (phase 1); after that all eligible candidates will be randomized 1:1 (phase 2).
Procedure: Loop Electrosurgical Excision Procedure (LEEP) followed by implantation of the device called DUDA (plastic device developed in barretos cancer hospital that will be placed after conization. It has 2.5 cm in length and 5mm in diameter and remains within the endocervical canal for 30 days and is set at 4 points with nonabsorbable sutures in the ectocervix.) Receives: Device: DUDA device; Procedure: LEEP |
| Control group | Active comparator | The number of patients to be recruited in this arm will be 120.
Procedure: Loop Electrosurgical Excision Procedure (LEEP) without DUDA device Receives: Procedure: LEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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
Measured: 6 months
Secondary outcomes (3)
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).
Measured: 6 months
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.
Measured: 30 days
View of the squamo-columnar junction (SCJ) of the cervix
It will be assessed during the examination of colposcopy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2018
- Study completion7 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosis CervixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Reis, PHD, Study director, Director of the Teaching and Research Institute - Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500966
- Sponsor's protocol ID
- BarretosCH - DUDA
- Acronym
- DUDA
- Status last verified
- Jun 2018
- First submitted
- 15 Jul 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02500966
- Acronym / sponsor ID
- DUDA / BarretosCH - DUDA
- Conditions
- Stenosis Cervix
- Keywords
- Cervical Intraepithelial Neoplasia, stenosis, cervix, medical device, inventories, Uterine Cervix, Intrauterine Devices, intrauterine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This device has the potential to improve outcomes by means of a significant stenosis reduction and maintain patency of the endocervical canal to view the squamo-columnar junction (SCJ) of the cervix during follow-up of this patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DUDA device | Experimental | Device: DUDA device, Procedure: LEEPThe number of patients to be recruited in this arm will be 145. Note: The first twenty-five patients who will be included in the study will be allocated in the intervention arm to safety analysis (phase 1); after that all eligible candidates will be randomized 1:1 (phase 2). Procedure: Loop Electrosurgical Excision Procedure (LEEP) followed by implantation of the device called DUDA (plastic device developed in barretos cancer hospital that will be placed after conization. It has 2.5 cm in length and 5mm in diameter and remains within the endocervical canal for 30 days and is set at 4 points with nonabsorbable sutures in the ectocervix.) |
| Control group | Active comparator | Procedure: LEEPThe number of patients to be recruited in this arm will be 120. Procedure: Loop Electrosurgical Excision Procedure (LEEP) without DUDA device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnancy
- Previous conization
- limited comprehension of the study
- the risk of the American Society of Anesthesiologists, III or IV
- HIV or immunodepression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DUDA deviceInsertion DUDA device | Device | DUDA device |
| LEEPLoop Electrosurgical Excision Procedure | Procedure or surgery | Control group, DUDA device |
Primary outcome
Safety (two adverse events Grade 3 or 4 (CTCAE v. 4.0) or a single adverse event Grade 5)
Time frame: 3 months
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.
Cervical stenosis
Time frame: 6 months
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
3 secondary outcomes
Pain Scales
Time frame: 6 months
Complications
Time frame: 30 days
View of the squamo-columnar junction (SCJ) of the cervix
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Reis, PHD study director
Director of the Teaching and Research Institute - Barretos Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DUDA device and LEEP in people with Stenosis Cervix, run by Barretos Cancer Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (two adverse events Grade 3 or 4 (CTCAE v. 4.0) or a single adverse event Grade 5) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.