Pelvic Organ ProlapseNCT02320643
A Pilot Study to Investigate the Efficacy of Partially Absorbable Mesh in Patients With Pelvic Organ Prolapsed
A study testing Seratom® PA mesh in people with Pelvic Organ Prolapse, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy, recurrence, postoperative complications of partially absorbable mesh(Seratom®PA) in patients with pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 41 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Seratom® PA mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Apr 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 41 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman who aged 41 years or older
- Subjects who have symptomatic pelvic organ prolapse quantification(POP-Q) stage II \& cystocele or higher requiring surgical repair
- Subjects who desires vaginal reconstructive surgery
- Subjects who have uterus < 12 weeks size
- Subjects who are able to complete study questionnaires and assessment
- Subjects who are available for 6 months follow-up
Who cannot join
- Subjects who have medical contractions, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use, or a compromised immune system
- Subjects who have received anticoagulation therapy
- Subjects who are on current intermittent catheterization
- Subjects whose BMI is over 30kg/m2
- Subjects who have uncontrolled diabetes
- Subjects who are on any medication which could result in compromised immune response, such as immune modulators
Show all 16Show fewer
- Subjects who are currently pregnant or intends to become pregnant during the study period or <12 months post-partum
- Subjects who have received other laparoscopic or abdominal or pelvic surgery in the past 1 months
- Subjects who need for concomitant surgery requiring an abdominal incision
- Subjects who have had a prior prolapse implant procedure (i.e. IVS tunneler, Perigee, Apogee, graft augmented repair, etc)
- Note: previous traditional repairs are allowed.
- Subjects who have had radiation therapy to the pelvic area
- Subjects who have pelvic cancer or have had pelvic cancer within the past 12 months or have had on cytostatic medication within the past 12 months
- Subjects who have a shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys.)
- Subjects who have a known neurologic or medical condition affecting bladder function (e.g. Multiple Sclerosis, spinal cord injury)
- Subjects who have a known hypersensitivity to the graft material(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Pilot Study to Investigate the Efficacy of Partially Absorbable Mesh(Seratom PA®) in Patients With Pelvic Organ Prolapsed
The purpose of this study is to evaluate the efficacy, recurrence, postoperative complications of partially absorbable mesh(Seratom®PA) in patients with pelvic organ prolapse.
Read the detailed description
Patients with pelvic organ prolapse are administrated partially absorbable mesh(Seratom®PA). It is performed pelvic organ prolapse quantification(POP-Q) examination, quality of life(QOL) questionnaire complications at postop 2week, 12week, 24week.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Seratom® PA mesh
- Keywords
- Partially absorbable mesh
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seratom® PA meshDevice
Partially absorbable mesh
| Study group | Role | What they receive |
|---|---|---|
| Seratom® PA mesh | Experimental | Partially absorbable mesh Receives: Device: Seratom® PA mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse Quantification(POP-Q) stage
Measured: Change from baseline in Pelvic Organ Prolapse Quantification(POP-Q) stage at postop 2week, 12week, 24week
Surgical revision rate
Measured: For post op 6 months from baseline
Secondary outcomes (1)
No of patients complications occurred
Measured: For post op 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kwon Sang Hoon, Doctor, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320643
- Sponsor's protocol ID
- POP-SERATOM PA
- Status last verified
- Apr 2017
- First submitted
- 9 Dec 2014
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study to Investigate the Efficacy of Partially Absorbable Mesh(Seratom PA®) in Patients With Pelvic Organ Prolapsed
- ClinicalTrials.gov ID
- NCT02320643
- Acronym / sponsor ID
- POP-SERATOM PA
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Partially absorbable mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 19 Dec 2014 (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 study is to evaluate the efficacy, recurrence, postoperative complications of partially absorbable mesh(Seratom®PA) in patients with pelvic organ prolapse.
Detailed description
Patients with pelvic organ prolapse are administrated partially absorbable mesh(Seratom®PA). It is performed pelvic organ prolapse quantification(POP-Q) examination, quality of life(QOL) questionnaire complications at postop 2week, 12week, 24week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seratom® PA mesh | Experimental | Device: Seratom® PA meshPartially absorbable mesh |
Who may qualify
- Ages
- 41 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Woman who aged 41 years or older
- Subjects who have symptomatic pelvic organ prolapse quantification(POP-Q) stage II \& cystocele or higher requiring surgical repair
- Subjects who desires vaginal reconstructive surgery
- Subjects who have uterus < 12 weeks size
- Subjects who are able to complete study questionnaires and assessment
Key exclusion criteria (16 listed)
- Subjects who have medical contractions, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use, or a compromised immune system
- Subjects who have received anticoagulation therapy
- Subjects who are on current intermittent catheterization
- Subjects whose BMI is over 30kg/m2
- Subjects who have uncontrolled diabetes
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 |
|---|---|---|
| Seratom® PA meshPartially absorbable mesh | Device | Seratom® PA mesh |
Primary outcome
Pelvic Organ Prolapse Quantification(POP-Q) stage
Time frame: Change from baseline in Pelvic Organ Prolapse Quantification(POP-Q) stage at postop 2week, 12week, 24week
Surgical revision rate
Time frame: For post op 6 months from baseline
1 secondary outcome
No of patients complications occurred
Time frame: For post op 6 months from baseline
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 1 May 2017.
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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.
Kwon Sang Hoon, Doctor principal investigator
Keimyung University Dongsan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seratom® PA mesh in people with Pelvic Organ Prolapse, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
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 6 inclusion and 16 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 1 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 South Korea. 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?
Pelvic Organ Prolapse Quantification(POP-Q) stage (time frame: Change from baseline in Pelvic Organ Prolapse Quantification(POP-Q) stage at postop 2week, 12week, 24week). 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 1 May 2017.