No Placental AbruptionHEMOGYNNCT01589744
Proof of Concept Study of a Sucker Hemostatic Intra Uterine in Postpartum Hemorrhage After Abruptio Placenta Assisted
A study testing Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed) in people with No Placental Abruption and No Hemorrhage, run by AdministrateurCIC at 1 site in France.
Trial summary
The postpartum hemorrhage (PPH) is the major complication of the delivery. In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- No Placental Abruption, No Hemorrhage
- What is being tested?
- Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Mar 2015
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- woman between 18 and 45 years old,
- affiliation to the French social security system or equivalent,
- volunteers signed a consent to participate,
- volunteer is under loco-regional anaesthesia,
- volunteer whose the placenta has not taken off after 30 minutes despite the directed delivery.
Who cannot join
- volunteer carries uterine malformations,
- volunteer with post-partum haemorrhage (blood loss> 500 ml),
- volunteer allergic to silicon,
- volunteer under general anaesthesia,
- pregnancy not unique,
- volunteer with fever or suspected infection during labor,
Show all 10Show fewer
- Person deprived of freedom by judicial or administrative decision
- Person hospitalized without their consent
- Person under legal protection
- Person hospitalized for psychiatric care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vacuum Device for Hemostasis in Obstetrics and Gynecology: Proof of Concept Study in the Post Partum Hemorrhage
The postpartum hemorrhage (PPH) is the major complication of the delivery. In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. Escalating therapy after obstetric maneuvers (placenta, uterus, examination of the birth canal), begins with uterotonic treatments for invasive treatments lead to embolization, vessel ligation and hysterectomy. However, the morbidity of these techniques and the desire to preserve fertility required to devise new therapeutic solutions, which have recently led to the development of an innovative medical device intrauterine hemostasis.
The postpartum haemorrhage are mainly the result of weak and bleeding from the surface corresponds to the placental insertion, which is no longer localized. With the innovative medical device, our main hypothesis is that the uterine walls will append to the walls of the cup after depressurization of the latter. The actuation of the suction cup will lead to aspiration of all sides of the uterus (it is mostly the anterior and posterior that are important). The suction cup is flexible to adapt to the size of the uterus in order to be placed and removed easily from the uterine cavity.
Read the detailed description
In this study, as a first pass in Human, innovative medical device not CE marked, we did not aim to show control of the bleeding stops in the case of PPH but to prove, in a clinical situation with no foreseeable risk to the volunteers included (volunteers who have given birth without placental abruption after 30 minutes despite the directed delivery), proof of concept of using this system in these women that creates a vacuum in the Intra uterine Haemostatic vacuum and thus a joining of the walls of the uterus. This first step seems essential in order to effectively implement this medical device with serenity in emergency situations of PPH.
- Conditions
- No Placental Abruption, No Hemorrhage
- Being tested
- Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)
- Keywords
- medical device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)Device
The haemostatic intra-uterine suction-cup is introduced in uterus and a depressure in this device is applied. This medical device is used for 5 minutes at maximum.
| Study group | Role | What they receive |
|---|---|---|
| Suction cup Hemostatic Intra-Uterin | Experimental | The suction haemostatic cup will be positioned into the uterus, and the aim is to stop haemorrhage Receives: Device: Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants for which there is a joining of the walls of the uterus around the suction cup after the depressurization.
Comparison of ultrasound images before and after depression in the suction cup. The joining of tissues on the suction cup is characterized by a better visualization of posterior structures following the depressurization by eliminating air in the haemostatic intra-uterine suction cup.
Measured: 18 month
Secondary outcomes (3)
Number of participants for which the setting up of the suction cup in uterus is a successful.
Qualification of success or failure of the setting up and score between 0 and 10 on a Visual,quantitative satisfaction scale.
Measured: 18 month
Number of participant for which there is a persistence of the joining walls of the uterus around the suction cup between 1 and 5 minutes at maximum after passage of the depression with Redon Drainobag®.
Measured: 18 month
Number of participants for which the withdrawal of the suction cup from the uterus is a successful.
Qualification of success or failure of natural withdrawal of the suction cup and score between 0 and 10 on a visual, quantitative satisfaction scale.
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Non adequation between the medical device and the study population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Placental AbruptionStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdministrateurCIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AdministrateurCIC, University Hospital, Grenoble
- Investigators
- Véronique Equy, MD, Principal investigator, Clinic of Gynecology and Obstetrics, University Hospital Grenoble - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589744
- Sponsor's protocol ID
- DCIC 11 24
- Acronym
- HEMOGYN
- Status last verified
- Oct 2016
- First submitted
- 25 Apr 2012
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacuum Device for Hemostasis in Obstetrics and Gynecology: Proof of Concept Study in the Post Partum Hemorrhage
- ClinicalTrials.gov ID
- NCT01589744
- Acronym / sponsor ID
- HEMOGYN / DCIC 11 24
- Conditions
- No Placental Abruption, No Hemorrhage
- Keywords
- medical device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Non adequation between the medical device and the study population
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AdministrateurCICUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 May 2012 (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 postpartum hemorrhage (PPH) is the major complication of the delivery. In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. Escalating therapy after obstetric maneuvers (placenta, uterus, examination of the birth canal), begins with uterotonic treatments for invasive treatments lead to embolization, vessel ligation and hysterectomy. However, the morbidity of these techniques and the desire to preserve fertility required to devise new therapeutic solutions, which have recently led to the development of an innovative medical device intrauterine hemostasis.
The postpartum haemorrhage are mainly the result of weak and bleeding from the surface corresponds to the placental insertion, which is no longer localized. With the innovative medical device, our main hypothesis is that the uterine walls will append to the walls of the cup after depressurization of the latter. The actuation of the suction cup will lead to aspiration of all sides of the uterus (it is mostly the anterior and posterior that are important). The suction cup is flexible to adapt to the size of the uterus in order to be placed and removed easily from the uterine cavity.
Detailed description
In this study, as a first pass in Human, innovative medical device not CE marked, we did not aim to show control of the bleeding stops in the case of PPH but to prove, in a clinical situation with no foreseeable risk to the volunteers included (volunteers who have given birth without placental abruption after 30 minutes despite the directed delivery), proof of concept of using this system in these women that creates a vacuum in the Intra uterine Haemostatic vacuum and thus a joining of the walls of the uterus. This first step seems essential in order to effectively implement this medical device with serenity in emergency situations of PPH.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suction cup Hemostatic Intra-Uterin | Experimental | Device: Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)The suction haemostatic cup will be positioned into the uterus, and the aim is to stop haemorrhage |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- woman between 18 and 45 years old,
- affiliation to the French social security system or equivalent,
- volunteers signed a consent to participate,
- volunteer is under loco-regional anaesthesia,
- volunteer whose the placenta has not taken off after 30 minutes despite the directed delivery.
Key exclusion criteria (10 listed)
- volunteer carries uterine malformations,
- volunteer with post-partum haemorrhage (blood loss> 500 ml),
- volunteer allergic to silicon,
- volunteer under general anaesthesia,
- pregnancy not unique,
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 |
|---|---|---|
| Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)The haemostatic intra-uterine suction-cup is introduced in uterus and a depressure in this device is applied. This medical device is used for 5 minutes at maximum. | Device | Suction cup Hemostatic Intra-Uterin |
Primary outcome
Number of participants for which there is a joining of the walls of the uterus around the suction cup after the depressurization.
Time frame: 18 month
Comparison of ultrasound images before and after depression in the suction cup. The joining of tissues on the suction cup is characterized by a better visualization of posterior structures following the depressurization by eliminating air in the haemostatic intra-uterine suction cup.
3 secondary outcomes
Number of participants for which the setting up of the suction cup in uterus is a successful.
Time frame: 18 month
Number of participant for which there is a persistence of the joining walls of the uterus around the suction cup between 1 and 5 minutes at maximum after passage of the depression with Redon Drainobag®.
Time frame: 18 month
Number of participants for which the withdrawal of the suction cup from the uterus is a successful.
Time frame: 18 month
Results and safety
The study was stopped early (reason given: Non adequation between the medical device and the study population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Related InfoLink provided by the sponsor.
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.
Véronique Equy, MD principal investigator
Clinic of Gynecology and Obstetrics, University Hospital Grenoble - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed) in people with No Placental Abruption and No Hemorrhage, run by AdministrateurCIC at 1 site in France.
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 10 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: stopped early, as of the sponsor's last update on 18 Oct 2016. 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 France. 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 was stopped early (reason given: Non adequation between the medical device and the study population). Results are not available in the source record.
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?
Number of participants for which there is a joining of the walls of the uterus around the suction cup after the depressurization. (time frame: 18 month). 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 Oct 2016.