Intrauterine AdhesionNCT03330873
The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome
A study testing disposable balloon uterine stent and Foley catheter in people with Intrauterine Adhesion, run by Beijing Obstetrics and Gynecology Hospital at 1 site in China.
Trial summary
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- disposable balloon uterine stent and Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2017to 20 Oct 2018
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age 20-40 years;
- Moderate to severe intrauterine adhesion (AFS score ≥5）;
- complains of menstruation disorder and reproductive dysfunction
- Agreement to have second-look hysteroscopy
- informed consent
Who cannot join
- ovarian failure
- patients who did not proceed to second-look hysteroscopy within the specified time frame
- Contraindication of hormone
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Obstetrics and Gynecology Hospital，Capital Medical University
Beijing, Beijing Municipality, 100006
Liu Zhen, +8613718210767, fcyykyb@163.com
About this study
Official title: Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent and Foley Catheter in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. The isolation of barriers in the uterine cavity may be a measure to reduce postoperative re adhesion, but the effect of different devices is different. Therefore, this study was conducted.
Read the detailed description
The Foley catheter is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 5-7th day after surgery. Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.
- Conditions
- Intrauterine Adhesion
- Being tested
- disposable balloon uterine stent, Foley catheter
- Keywords
- Asherman syndrome, disposable balloon uterine stent, hysteroscopy, Foley catheter
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disposable balloon uterine stentDevice
The disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter
Foley catheterDevice
Foley catheter can partly separate the sides of uterus wall.
| Study group | Role | What they receive |
|---|---|---|
| Foley catheter | Experimental | After the completion of hysteroscopic adhesiolysis, Foley catheter was inserted and inflated with normal saline which was removed on the 7th day after surgery. Receives: Device: Foley catheter |
| Disposable balloon uterine stent | Experimental | After the completion of hysteroscopic adhesiolysis, disposable balloon uterine stent was inserted and inflated with normal saline which was removed on the 7th day after surgery. Receives: Device: disposable balloon uterine stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
second diagnostic hysteroscopy
AFS score（The American Fertility Society classifications）
Measured: Within the first 3 months after surgery
Secondary outcomes (2)
Menstruation Pattern
Improvement or No Significant Change
Measured: Within the first 3 months after surgery
Number of participants with pregnancy
Number of biochemical pregnancies and clinical pregnancies
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start23 Oct 2017
- Primary completion20 Aug 2018 (estimated)
- Study completion20 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine AdhesionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Obstetrics and Gynecology Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duan Hua, PhD, Study chair, Beijing Obstetrics and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330873
- Sponsor's protocol ID
- No.3-20140601
- Status last verified
- Oct 2017
- First submitted
- 18 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent and Foley Catheter in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
- ClinicalTrials.gov ID
- NCT03330873
- Acronym / sponsor ID
- No.3-20140601
- Conditions
- Intrauterine Adhesion
- Keywords
- Asherman syndrome, disposable balloon uterine stent, hysteroscopy, Foley catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Obstetrics and Gynecology HospitalUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 20 Aug 2018 (estimated)
- Study completion
- 20 Oct 2018 (estimated)
- First posted
- 6 Nov 2017 (actual)
- 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.
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. The isolation of barriers in the uterine cavity may be a measure to reduce postoperative re adhesion, but the effect of different devices is different. Therefore, this study was conducted.
Detailed description
The Foley catheter is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 5-7th day after surgery. Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foley catheter | Experimental | Device: Foley catheterAfter the completion of hysteroscopic adhesiolysis, Foley catheter was inserted and inflated with normal saline which was removed on the 7th day after surgery. |
| Disposable balloon uterine stent | Experimental | Device: disposable balloon uterine stentAfter the completion of hysteroscopic adhesiolysis, disposable balloon uterine stent was inserted and inflated with normal saline which was removed on the 7th day after surgery. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age 20-40 years;
- Moderate to severe intrauterine adhesion (AFS score ≥5）;
- complains of menstruation disorder and reproductive dysfunction
- Agreement to have second-look hysteroscopy
- informed consent
Key exclusion criteria (3 listed)
- ovarian failure
- patients who did not proceed to second-look hysteroscopy within the specified time frame
- Contraindication of hormone
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 |
|---|---|---|
| disposable balloon uterine stentThe disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter | Device | Disposable balloon uterine stent |
| Foley catheterFoley catheter can partly separate the sides of uterus wall. | Device | Foley catheter |
Primary outcome
second diagnostic hysteroscopy
Time frame: Within the first 3 months after surgery
AFS score（The American Fertility Society classifications）
2 secondary outcomes
Menstruation Pattern
Time frame: Within the first 3 months after surgery
Number of participants with pregnancy
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Duan Hua, PhD study chair
Beijing Obstetrics and Gynecology 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 disposable balloon uterine stent and Foley catheter in people with Intrauterine Adhesion, run by Beijing Obstetrics and Gynecology Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 6 Nov 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhu Ru, MD (+8613966636438, zhuru19790202@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
second diagnostic hysteroscopy (time frame: Within the first 3 months after surgery). 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 6 Nov 2017.