Cervix Uteri DilationNCT02851953
Effectiveness and Safety Evaluation of Aqueduct -100 Device
A study testing Aqueduct-100 in people with Cervix Uteri Dilation, run by Aqueduct Medical Ltd at 1 site in Italy.
Trial summary
The purpose of the present clinical investigation is to collect data regarding the safety and effectiveness of the Aqueduct 100 device. The effectiveness of the Aqueduct 100 will be determined by evaluating the ability to reach desired cervical dilation, and the time frame required to reach desired cervical dilation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Uteri Dilation
- What is being tested?
- Aqueduct-100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2016to Jan 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects, females, 18 years of age or older.
- Subjects undergoing any process that requires dilation (intrauterine procedures).
- Subjects understanding the nature of the study and willing to sign informed consent form.
Who cannot join
- Subjects younger than 18 years of age.
- Subject with the following infectious diseases: HIV, HBV, HCV, Syphilis.
- Subject has been treated with any cervix dilating agent within 2 months before the screening.
- Known contraindications or hypersensitivity to the components of the investigational product.
- The patient has a condition or a concurrent severe and/or uncontrolled medical disease which could compromise participation, compliance with, and/or completion with study procedures.
- Subjects undergoing abortion <7 and >9 weeks of pregnancy.
- Subjects unwilling to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Irccs Azienda Ospedaliera Universitaria San Martino Ist
Genova, 16132
About this study
The purpose of the present clinical investigation is to collect data regarding the safety and effectiveness of the Aqueduct 100 device.
The effectiveness of the Aqueduct 100 will be determined by evaluating the ability to reach desired cervical dilation, and the time frame required to reach desired cervical dilation.
- Conditions
- Cervix Uteri Dilation
- Being tested
- Aqueduct-100
- Keywords
- cervix, cervical dilation, balloon catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqueduct-100Device
| Study group | Role | What they receive |
|---|---|---|
| Aqueduct 100 dilation | Experimental | Uterine cervix dilation through Aqueduct-100 device Receives: Device: Aqueduct-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with dilation of cervix to a pre-determined diameter before the intrauterine procedure using Aqueduct-100 device.
The primary outcome of this study is to determine the effectiveness of the Aqueduct-100 device to dilate the uterine cervices to the desired diameter.
Measured: Through study completion, approximately 9 months
Secondary outcomes (3)
Occurrence of Adverse Events: rate, list and severity of AEs and SAEs.
In vivo safety evaluation of using Aqueduct-100.
Measured: Through study completion, approximately 9 months
Time frame required to reach desired cervical dilation from start time (insertion of device) to completion of dilation (removal of catheter)
Duration of the dilation procedure.
Measured: Through study completion, approximately 9 months
Measurement of physicians' satisfaction with the device, through the use of a questionnaire.
Measured: Through study completion, approximately 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cervix Uteri DilationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aqueduct Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sintesi Research Srl
- Responsible party
- Sponsor
- Investigators
- Pierluigi Venturini, Professor, Principal investigator, IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO ISTSimone Ferrero, Professor, Study director, IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851953
- Sponsor's protocol ID
- AQD 01-15
- Status last verified
- May 2017
- First submitted
- 25 Jul 2016
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Mazza E, Nava A, Bauer M, Winter R, Bajka M, Holzapfel GA. Mechanical properties of the human uterine cervix: an in vivo study. Med Image Anal. 2006 Apr;10(2):125-36. doi: 10.1016/j.media.2005.06.001. Epub 2005 Sep 6.
PubMed 16143559Buhimschi, C.; Buhimschi, I.; Malinow, A.; Saade, G.; Garfield, R.; Weiner, C., The Forces of Labour. Fetal and Maternal Medicine Review 2003, 14 (4), 273-307.
Myers KM, Paskaleva AP, House M, Socrate S. Mechanical and biochemical properties of human cervical tissue. Acta Biomater. 2008 Jan;4(1):104-16. doi: 10.1016/j.actbio.2007.04.009. Epub 2007 Sep 27.
PubMed 17904431Kenyon NJ, Stevens JC, Stewart P, Black MM, Clifford A. A critical investigation of the measurement of the force required to dilate the human uterine cervix. Clin Phys Physiol Meas. 1988 May;9(2):155-61. doi: 10.1088/0143-0815/9/2/008.
PubMed 3391017S. Febvay, S. Socrate and M.D. House. Biomechanical modeling of cervical tissue. A quantitative investigation of cervical funneling. Proceedings of the ASME 2003 International Mechanical Engineering Congress and Exposition, Washington, D.C., November 2003.
Arsenijevic S, Vukcevic-Globarevic G, Volarevic V, Macuzic I, Todorovic P, Tanaskovic I, Mijailovic M, Raicevic S, Jeremic B. Continuous controllable balloon dilation: a novel approach for cervix dilation. Trials. 2012 Oct 22;13:196. doi: 10.1186/1745-6215-13-196.
PubMed 23088906Nicolaides KH, Welch CC, MacPherson MB, Johnson IR, Filshie GM. Lamicel: a new technique for cervical dilatation before first trimester abortion. Br J Obstet Gynaecol. 1983 May;90(5):475-9. doi: 10.1111/j.1471-0528.1983.tb08947.x.
PubMed 6849849
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety Evaluation of Aqueduct -100 Device
- ClinicalTrials.gov ID
- NCT02851953
- Acronym / sponsor ID
- AQD 01-15
- Conditions
- Cervix Uteri Dilation
- Keywords
- cervix, cervical dilation, balloon catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Aqueduct Medical LtdIndustry (pharma, biotech, devices)
- Collaborators
- Sintesi Research Srl
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 2 Aug 2016 (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.
The purpose of the present clinical investigation is to collect data regarding the safety and effectiveness of the Aqueduct 100 device.
The effectiveness of the Aqueduct 100 will be determined by evaluating the ability to reach desired cervical dilation, and the time frame required to reach desired cervical dilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aqueduct 100 dilation | Experimental | Device: Aqueduct-100Uterine cervix dilation through Aqueduct-100 device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects, females, 18 years of age or older.
- Subjects undergoing any process that requires dilation (intrauterine procedures).
- Subjects understanding the nature of the study and willing to sign informed consent form.
Key exclusion criteria (7 listed)
- Subjects younger than 18 years of age.
- Subject with the following infectious diseases: HIV, HBV, HCV, Syphilis.
- Subject has been treated with any cervix dilating agent within 2 months before the screening.
- Known contraindications or hypersensitivity to the components of the investigational product.
- The patient has a condition or a concurrent severe and/or uncontrolled medical disease which could compromise participation, compliance with, and/or completion with study procedures.
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 |
|---|---|---|
| Aqueduct-100 | Device | Aqueduct 100 dilation |
Primary outcome
Percentage of patients with dilation of cervix to a pre-determined diameter before the intrauterine procedure using Aqueduct-100 device.
Time frame: Through study completion, approximately 9 months
The primary outcome of this study is to determine the effectiveness of the Aqueduct-100 device to dilate the uterine cervices to the desired diameter.
3 secondary outcomes
Occurrence of Adverse Events: rate, list and severity of AEs and SAEs.
Time frame: Through study completion, approximately 9 months
Time frame required to reach desired cervical dilation from start time (insertion of device) to completion of dilation (removal of catheter)
Time frame: Through study completion, approximately 9 months
Measurement of physicians' satisfaction with the device, through the use of a questionnaire.
Time frame: Through study completion, approximately 9 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 8 May 2017.
- Background: PubMed 16143559Mazza E, Nava A, Bauer M, Winter R, Bajka M, Holzapfel GA. Mechanical properties of the human uterine cervix: an in vivo study. Med Image Anal. 2006 Apr;10(2):125-36. doi: 10.1016/j.media.2005.06.001. Epub 2005 Sep 6.
- BackgroundBuhimschi, C.; Buhimschi, I.; Malinow, A.; Saade, G.; Garfield, R.; Weiner, C., The Forces of Labour. Fetal and Maternal Medicine Review 2003, 14 (4), 273-307.
- Background: PubMed 17904431Myers KM, Paskaleva AP, House M, Socrate S. Mechanical and biochemical properties of human cervical tissue. Acta Biomater. 2008 Jan;4(1):104-16. doi: 10.1016/j.actbio.2007.04.009. Epub 2007 Sep 27.
- Background: PubMed 3391017Kenyon NJ, Stevens JC, Stewart P, Black MM, Clifford A. A critical investigation of the measurement of the force required to dilate the human uterine cervix. Clin Phys Physiol Meas. 1988 May;9(2):155-61. doi: 10.1088/0143-0815/9/2/008.
- BackgroundS. Febvay, S. Socrate and M.D. House. Biomechanical modeling of cervical tissue. A quantitative investigation of cervical funneling. Proceedings of the ASME 2003 International Mechanical Engineering Congress and Exposition, Washington, D.C., November 2003.
- Background: PubMed 23088906Arsenijevic S, Vukcevic-Globarevic G, Volarevic V, Macuzic I, Todorovic P, Tanaskovic I, Mijailovic M, Raicevic S, Jeremic B. Continuous controllable balloon dilation: a novel approach for cervix dilation. Trials. 2012 Oct 22;13:196. doi: 10.1186/1745-6215-13-196.
- Background: PubMed 6849849Nicolaides KH, Welch CC, MacPherson MB, Johnson IR, Filshie GM. Lamicel: a new technique for cervical dilatation before first trimester abortion. Br J Obstet Gynaecol. 1983 May;90(5):475-9. doi: 10.1111/j.1471-0528.1983.tb08947.x.
- Individual participant dataSharing planned: Undecided
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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.
Pierluigi Venturini, Professor principal investigator
IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST
Simone Ferrero, Professor study director
IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqueduct-100 in people with Cervix Uteri Dilation, run by Aqueduct Medical Ltd at 1 site in Italy.
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 3 inclusion and 7 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 8 May 2017. 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 Italy. 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?
Percentage of patients with dilation of cervix to a pre-determined diameter before the intrauterine procedure using Aqueduct-100 device. (time frame: Through study completion, approximately 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02851953, which also lists 7 linked publications.
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 8 May 2017.