Laparoscopic MyomectomyNCT00624390
Sepraspray™ Laparoscopic Myomectomy Study
A study testing Sepraspray in people with Laparoscopic Myomectomy, run by Genzyme, a Sanofi Company at 3 sites in United States.
Trial summary
The purpose of this research study is to obtain preliminary data of the safety and effectiveness of Sepraspray in a limited number of patients who are under going a laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity following laparoscopic myomectomy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Laparoscopic Myomectomy
- What is being tested?
- Sepraspray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2007to Dec 2008
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The patient must be a premenopausal women with myomas associated with clinical symptoms deemed suitable for laparoscopic myomectomy and SLL.
Who cannot join
- Pregnant/lactating women.
- The patient has a history of hypersensitivity to exogenous carboxymethylcellulose products and/or hyaluronic acid.
- The patient's procedure resulted in entry of the endometrial cavity, or entry of the bowel including appendectomy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Austin, Texas
Study site
Naperville, Illinois
Study site
Philadelphia, Pennsylvania
About this study
Official title: A Randomized, Masked Patient, Independent Reviewer, Multi-Center Pilot Study to Evaluate the Feasibility of Sepraspray™ Adhesion Barrier in Laparoscopic Myomectomy
The purpose of this research study is to obtain preliminary data of the safety and effectiveness of Sepraspray in a limited number of patients who are under going a laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity following laparoscopic myomectomy. We will compare treatment with Sepraspray as a adhesion prevention barrier after laparoscopic myomectomy versus no adhesion barrier.
- Conditions
- Laparoscopic Myomectomy
- Being tested
- Sepraspray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeprasprayDevice
| Study group | Role | What they receive |
|---|---|---|
| Sepraspray | Experimental | Sepraspray applied directly to both sides of the uterus, Fallopian tubes, and ovaries (or opposing sites if not possible to apply directly). Sepraspray was applied via a sterile cannula at a tissue concentration of approximately 5 mg/cm^2. Receives: Device: Sepraspray |
| Control | No intervention | No anti-adhesion treatment was used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage.
Measured: 30 Days post surgery
Efficacy endpoints are on adhesion formation and will include the success the success criterion for the individual patients as either anterior or posterior uterus free of dense adhesions.
Measured: Until end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic MyomectomyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624390
- Sponsor's protocol ID
- SSPRAY00306
- Status last verified
- Dec 2016
- First submitted
- 15 Feb 2008
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Masked Patient, Independent Reviewer, Multi-Center Pilot Study to Evaluate the Feasibility of Sepraspray™ Adhesion Barrier in Laparoscopic Myomectomy
- ClinicalTrials.gov ID
- NCT00624390
- Acronym / sponsor ID
- SSPRAY00306
- Conditions
- Laparoscopic Myomectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Feb 2008 (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 this research study is to obtain preliminary data of the safety and effectiveness of Sepraspray in a limited number of patients who are under going a laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity following laparoscopic myomectomy. We will compare treatment with Sepraspray as a adhesion prevention barrier after laparoscopic myomectomy versus no adhesion barrier.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepraspray | Experimental | Device: SepraspraySepraspray applied directly to both sides of the uterus, Fallopian tubes, and ovaries (or opposing sites if not possible to apply directly). Sepraspray was applied via a sterile cannula at a tissue concentration of approximately 5 mg/cm^2. |
| Control | No intervention | –No anti-adhesion treatment was used. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The patient must be a premenopausal women with myomas associated with clinical symptoms deemed suitable for laparoscopic myomectomy and SLL.
Key exclusion criteria (3 listed)
- Pregnant/lactating women.
- The patient has a history of hypersensitivity to exogenous carboxymethylcellulose products and/or hyaluronic acid.
- The patient's procedure resulted in entry of the endometrial cavity, or entry of the bowel including appendectomy.
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 |
|---|---|---|
| Sepraspray | Device | Sepraspray |
Primary outcome
The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage.
Time frame: 30 Days post surgery
Efficacy endpoints are on adhesion formation and will include the success the success criterion for the individual patients as either anterior or posterior uterus free of dense adhesions.
Time frame: Until end of study
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 14 Dec 2016.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sepraspray in people with Laparoscopic Myomectomy, run by Genzyme, a Sanofi Company at 3 sites in United States.
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 1 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 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage. (time frame: 30 Days post surgery). 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 14 Dec 2016.