Hysteroscopic AdhesiolysisNCT02348541
Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis
A study testing CollaGUARD in people with Hysteroscopic Adhesiolysis, run by Innocoll at 2 sites in Netherlands.
Trial summary
Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hysteroscopic Adhesiolysis
- What is being tested?
- CollaGUARD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesNetherlands
- Study dates
- Dec 2014to Sep 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
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with intrauterine adhesions and found eligible for hysteroscopic adhesiolysis
- Willing to use additional contraception throughout study
Who cannot join
- Be pregnant or having a suspected molar pregnancy, lactating, or planning to become pregnant at any time during the study
- Has suffered or currently suffers from a gynaecological malignancy
- Has undergone a previous hysteroscopic surgery (such as removal of fibroids)
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Sint Lucas Andreas Ziekenhuis
Amsterdam
Spaarne Ziekenhuis
Hoofddorp
About this study
Official title: A Post-Market Clinical Follow-up Study to Investigate the Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis
Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.
Read the detailed description
Intrauterine adhesions following gynaecological surgery is a major complication which may cause a range of severe clinical symptoms in women. IUA's can result in menstrual abnormalities, dysmenorrhea and infertility. In pregnancy, adhesions are related to miscarriage, ectopic pregnancy, abnormal placentation, premature labor and delivery and possibly birth defects.
CollaGUARD adhesion barrier is a transparent bioresorbable film approved in Europe for the prevention of postoperative adhesions in patients undergoing abdomino-pelvic laparotomy or laparoscopy.
This study will assess the feasibility of using CollaGUARD adhesion device in hysteroscopic surgery.
- Conditions
- Hysteroscopic Adhesiolysis
- Being tested
- CollaGUARD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CollaGUARDDevice
| Study group | Role | What they receive |
|---|---|---|
| CollaGUARD | Other | Not described Receives: Device: CollaGUARD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire
surgeon completed questionnaire
Measured: following initial hysteroscopy
Secondary outcomes (3)
Number of de novo adhesion and adhesion reformation
assessed during follow-up hysteroscopy
Measured: 9 weeks post initial hysteroscopy
Change in severity of adhesions
European Society Gynecological Endoscopy (ESGE) classification of IUA's; modified American Fertility Society (mAFS)
Measured: 9 weeks post initial hysteroscopy
Degradation of CollaGUARD
assessed via ultrasound
Measured: 2 weeks post initial hysteroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysteroscopic AdhesiolysisStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innocoll
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Prior, PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348541
- Sponsor's protocol ID
- INN-CG-001
- Status last verified
- Sep 2021
- First submitted
- 19 Jan 2015
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Clinical Follow-up Study to Investigate the Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis
- ClinicalTrials.gov ID
- NCT02348541
- Acronym / sponsor ID
- INN-CG-001
- Conditions
- Hysteroscopic Adhesiolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- InnocollIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 Jan 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.
Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.
Detailed description
Intrauterine adhesions following gynaecological surgery is a major complication which may cause a range of severe clinical symptoms in women. IUA's can result in menstrual abnormalities, dysmenorrhea and infertility. In pregnancy, adhesions are related to miscarriage, ectopic pregnancy, abnormal placentation, premature labor and delivery and possibly birth defects.
CollaGUARD adhesion barrier is a transparent bioresorbable film approved in Europe for the prevention of postoperative adhesions in patients undergoing abdomino-pelvic laparotomy or laparoscopy.
This study will assess the feasibility of using CollaGUARD adhesion device in hysteroscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CollaGUARD | Other | Device: CollaGUARD |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with intrauterine adhesions and found eligible for hysteroscopic adhesiolysis
- Willing to use additional contraception throughout study
Key exclusion criteria (3 listed)
- Be pregnant or having a suspected molar pregnancy, lactating, or planning to become pregnant at any time during the study
- Has suffered or currently suffers from a gynaecological malignancy
- Has undergone a previous hysteroscopic surgery (such as removal of fibroids)
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 |
|---|---|---|
| CollaGUARD | Device | CollaGUARD |
Primary outcome
Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire
Time frame: following initial hysteroscopy
surgeon completed questionnaire
3 secondary outcomes
Number of de novo adhesion and adhesion reformation
Time frame: 9 weeks post initial hysteroscopy
Change in severity of adhesions
Time frame: 9 weeks post initial hysteroscopy
Degradation of CollaGUARD
Time frame: 2 weeks post initial hysteroscopy
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 10 Sep 2021.
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.
David Prior, PhD study director
Sponsor GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CollaGUARD in people with Hysteroscopic Adhesiolysis, run by Innocoll at 2 sites in Netherlands.
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 2 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: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire (time frame: following initial hysteroscopy). 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 10 Sep 2021.