Tissue AdhesionNCT04063085
The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions
A study testing PROTAHERE Absorbable Adhesion Barrier, Hyalobarrier Gel and No treatment in people with Tissue Adhesion and Gynecologic Surgery, run by SciVision Biotech Inc. at 1 site in Taiwan.
Trial summary
The aim of this study is to assess the safety and effectiveness of PROTAHERE Absorbable Adhesion Barrier to prevent pelvic postoperative adhesions. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tissue Adhesion, Gynecologic Surgery
- What is being tested?
- PROTAHERE Absorbable Adhesion Barrier, Hyalobarrier Gel and No treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Apr 2018to 12 Oct 2023
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are premenopausal.
- Patients who are scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy.
- Patients who are 20 years old or older.
- Patients who are able to understand the objectives, sign the informed consent form, and willing to comply with study procedures.
Who cannot join
- Patients who are 65 years old or older.
- Presence of uncontrolled diabetes, coagulative disorders, severe urinary system infection, or other severe diseases.
- Presence of malignant tumor or diagnosed with cancer.
- Any physical or psychological illness or symptom which is considered unsuitable to enroll by physicians.
- Patients who are unwilling to comply with study procedures.
- Patients who are known to have hypersensitivity to hyaluronic acid implants.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess the safety and effectiveness of PROTAHERE Absorbable Adhesion Barrier to prevent pelvic postoperative adhesions.
Read the detailed description
The study is a random, evaluator-blinded, controlled, single center clinical trial. Recruiting patients who are premenopausal and scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy. Patients recruited are randomly divided into five groups, PROTAHERE, Hyalobarrier, Seprafilm, Interceed or no treatment when the inclusion criteria are met and the inform consents are obtained. They are followed for 24 months including visits at 14 days, 3, 6, 12, 18, 24 months post-operation for the safety and effectiveness evaluation. The primary endpoints are the incidence of adhesions at 3-month as well as the incidence of any adverse events during the study.
- Conditions
- Tissue Adhesion, Gynecologic Surgery
- Being tested
- PROTAHERE Absorbable Adhesion Barrier, Hyalobarrier Gel, No treatment, Seprafilm Adhesion Barrier, Gynecare Interceed (TC7) Absorbable Adhesion Barrier
- Keywords
- Hyaluronan, gel, adhesion agent
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROTAHERE Absorbable Adhesion BarrierDevice
40 mg/ml (4%) cross-linked hyaluronan
Hyalobarrier GelDevice
Laparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan
No treatmentOther
No anti-adhesion agent applied
Seprafilm Adhesion BarrierDevice
a hyaluronate carboxymethylcellulose-based bioresorbable membrane
Gynecare Interceed (TC7) Absorbable Adhesion BarrierDevice
an oxidized regenerated cellulose absorbable membrane
| Study group | Role | What they receive |
|---|---|---|
| PROTAHERE group | Experimental | The PROTAHERE group received intra-pelvic PROTAHERE Absorbable Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months. Receives: Device: PROTAHERE Absorbable Adhesion Barrier |
| Hyalobarrier group | Active comparator | The Hyalobarrier group received intra-pelvic Hyalobarrier Gel during the scheduled pelvic surgery and be followed for 24 months. Receives: Device: Hyalobarrier Gel |
| No treatment group | Sham comparator | The no treatment group did not receive any anti-adhesion agent during the scheduled pelvic surgery and be followed for 24 months. Receives: Other: No treatment |
| Seprafilm group | Active comparator | The Seprafilm group received intra-pelvic Seprafilm Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months. Receives: Device: Seprafilm Adhesion Barrier |
| Interceed group | Active comparator | The Interceed group received intra-pelvic Gynecare Interceed (TC7) Absorbale Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months. Receives: Device: Gynecare Interceed (TC7) Absorbable Adhesion Barrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative adhesion at 3 months
Divide the number of patients with postoperative adhesion at 3 months in each group by the total number of patients enrolled.
Measured: 3 months post-operation
Secondary outcomes (12)
The incidence of adverse events in each group from the baseline and during the study period
Divide the number of patients who suffered from adverse events by the number of patients enrolled in each group.
Measured: 14 days, 3, 6, 12, 18, 24 months
The incidence of each adverse event from the baseline and during the study
Divide the number of each adverse event by the number of total adverse events.
Measured: 14 days, 3, 6, 12, 18, 24 months
The severity of adverse events
The severity of adverse events are evaluated by blinded evaluators. The severity is classified into slight (no requirement for treatment), moderate (required for treatments, hospitalization or hospitalization prolongation) and serious (death, life-threatening, required for intensive care, required 7 days or longer time for recovery, permanent disability or congenital malformation)
Measured: 14 days, 3, 6, 12, 18, 24 months
The change of medication or treatment related to adverse event
The change of time or dose of the medication or treatment in each group are evaluated by blinded evaluators.
Measured: 14 days, 3, 6, 12, 18, 24 months
The proportion of sites with adhesions at 3 months
Divide the number of sites with adhesions by the total number of sites observed.
Measured: 3 months post-operation
The score of adhesion severity and extent at each sites at 3 months
Scoring method published by America Fertility Society:
The score of filmy adhesions with less than 1/3 enclosure is 1. The score of filmy adhesions with 1/3-2/3 enclosure is 2. The score of filmy adhesions with more than 2/3 enclosure is 4. The score of dense adhesions with less than 1/3 enclosure is 4. The score of dense adhesions with 1/3-2/3 enclosure is 8. The score of dense adhesions with more than 2/3 enclosure is 16. Higher score indicates more severe and extent adhesions, and represents worse outcome.
Measured: 3 months post-operation
The total score of America Fertility Society classifications of adhesions at all sites in each group at 3 months
Scoring method published by America Fertility Society:
The score of filmy adhesions with less than 1/3 enclosure is 1. The score of filmy adhesions with 1/3-2/3 enclosure is 2. The score of filmy adhesions with more than 2/3 enclosure is 4. The score of dense adhesions with less than 1/3 enclosure is 4. The score of dense adhesions with 1/3-2/3 enclosure is 8. The score of dense adhesions with more than 2/3 enclosure is 16. The evaluated sites include anterior and posterior uterus, anterior and posterior cul-de-sac, left and right pelvic sidewall, left and right ovaries, left and right tubes, small bowel, large bowel, omentum, left and right abdominal wall as well as the incision, left and right broad ligament, left and right round ligament of uterus. Sum up all the adhesion scores at all sites in each group. The minimum total score is 0 and the maximum total score is 320. Higher score indicates more severe and extent adhesions, and represents worse outcome.
Measured: 3 months post-operation
The incidence of postoperative adhesion from the baseline and during the study period
Divide the number of patients with postoperative adhesion from the baseline and during the study in each group by the total number of patients enrolled.
Measured: 14 days, 3, 6, 12, 18, 24 months
The change of CA125 value in each group during the study period
CA125 value (U/ml) is considered as one of the indexes of pelvic inflammation.
Measured: 3, 6, 12, 18, 24 months
The change of the results of SF-36 questionnaire in each group from the baseline and during the study period
SF-36 questionnaires are filled out by patients to evaluate their health status during the study period. 8 categories of scales are evaluated including physical functioning, role limitations due to physical or emotional problems, energy/fatigue, emotional well beings, social functioning, pain and general health. For each category, the minimum average score is 0 and the maximum average score is 100. Higher score indicates better health status, which represents a better outcome.
Measured: 14 days, 3, 6, 12, 18, 24 months
The residual status of anti-adhesion agents at 3 months
The residual status of anti-adhesion agents at each site is evaluated by blinded evaluators. No residue is scored to be 0, and with residue is scored to be 1. Sum up the scores of all sites in each group.
Measured: 3 months post-operation
Visual analog scale (VAS) score for pain change
Patients enrolled who had endometriosis or intra-pelvic adhesions would subjectively evaluate their feeling of pain through a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain' during the study period.
Measured: 14 days, 3, 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start25 Apr 2018
- Primary completion5 Jan 2022
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- SciVision Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063085
- Sponsor's protocol ID
- RDCT-TWPH
- Status last verified
- Apr 2023
- First submitted
- 19 Aug 2019
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions
- ClinicalTrials.gov ID
- NCT04063085
- Acronym / sponsor ID
- RDCT-TWPH
- Conditions
- Tissue Adhesion, Gynecologic Surgery
- Keywords
- Hyaluronan, gel, adhesion agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- SciVision Biotech Inc.Industry (pharma, biotech, devices)
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 21 Aug 2019 (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.
The aim of this study is to assess the safety and effectiveness of PROTAHERE Absorbable Adhesion Barrier to prevent pelvic postoperative adhesions.
Detailed description
The study is a random, evaluator-blinded, controlled, single center clinical trial. Recruiting patients who are premenopausal and scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy. Patients recruited are randomly divided into five groups, PROTAHERE, Hyalobarrier, Seprafilm, Interceed or no treatment when the inclusion criteria are met and the inform consents are obtained. They are followed for 24 months including visits at 14 days, 3, 6, 12, 18, 24 months post-operation for the safety and effectiveness evaluation. The primary endpoints are the incidence of adhesions at 3-month as well as the incidence of any adverse events during the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PROTAHERE group | Experimental | Device: PROTAHERE Absorbable Adhesion BarrierThe PROTAHERE group received intra-pelvic PROTAHERE Absorbable Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months. |
| Hyalobarrier group | Active comparator | Device: Hyalobarrier GelThe Hyalobarrier group received intra-pelvic Hyalobarrier Gel during the scheduled pelvic surgery and be followed for 24 months. |
| No treatment group | Sham comparator | Other: No treatmentThe no treatment group did not receive any anti-adhesion agent during the scheduled pelvic surgery and be followed for 24 months. |
| Seprafilm group | Active comparator | Device: Seprafilm Adhesion BarrierThe Seprafilm group received intra-pelvic Seprafilm Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months. |
| Interceed group | Active comparator | Device: Gynecare Interceed (TC7) Absorbable Adhesion BarrierThe Interceed group received intra-pelvic Gynecare Interceed (TC7) Absorbale Adhesion Barrier during the scheduled pelvic surgery and be followed for 24 months. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are premenopausal.
- Patients who are scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy.
- Patients who are 20 years old or older.
- Patients who are able to understand the objectives, sign the informed consent form, and willing to comply with study procedures.
Key exclusion criteria (6 listed)
- Patients who are 65 years old or older.
- Presence of uncontrolled diabetes, coagulative disorders, severe urinary system infection, or other severe diseases.
- Presence of malignant tumor or diagnosed with cancer.
- Any physical or psychological illness or symptom which is considered unsuitable to enroll by physicians.
- Patients who are unwilling to comply with study procedures.
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 |
|---|---|---|
| PROTAHERE Absorbable Adhesion Barrier40 mg/ml (4%) cross-linked hyaluronan | Device | PROTAHERE group |
| Hyalobarrier GelLaparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan | Device | Hyalobarrier group |
| No treatmentNo anti-adhesion agent applied | Other | No treatment group |
| Seprafilm Adhesion Barriera hyaluronate carboxymethylcellulose-based bioresorbable membrane | Device | Seprafilm group |
| Gynecare Interceed (TC7) Absorbable Adhesion Barrieran oxidized regenerated cellulose absorbable membrane | Device | Interceed group |
Primary outcome
The incidence of postoperative adhesion at 3 months
Time frame: 3 months post-operation
Divide the number of patients with postoperative adhesion at 3 months in each group by the total number of patients enrolled.
12 secondary outcomes
The incidence of adverse events in each group from the baseline and during the study period
Time frame: 14 days, 3, 6, 12, 18, 24 months
The incidence of each adverse event from the baseline and during the study
Time frame: 14 days, 3, 6, 12, 18, 24 months
The severity of adverse events
Time frame: 14 days, 3, 6, 12, 18, 24 months
The change of medication or treatment related to adverse event
Time frame: 14 days, 3, 6, 12, 18, 24 months
The proportion of sites with adhesions at 3 months
Time frame: 3 months post-operation
The score of adhesion severity and extent at each sites at 3 months
Time frame: 3 months post-operation
The total score of America Fertility Society classifications of adhesions at all sites in each group at 3 months
Time frame: 3 months post-operation
The incidence of postoperative adhesion from the baseline and during the study period
Time frame: 14 days, 3, 6, 12, 18, 24 months
The change of CA125 value in each group during the study period
Time frame: 3, 6, 12, 18, 24 months
The change of the results of SF-36 questionnaire in each group from the baseline and during the study period
Time frame: 14 days, 3, 6, 12, 18, 24 months
The residual status of anti-adhesion agents at 3 months
Time frame: 3 months post-operation
Visual analog scale (VAS) score for pain change
Time frame: 14 days, 3, 6, 12, 18, 24 months
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 17 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROTAHERE Absorbable Adhesion Barrier, Hyalobarrier Gel and No treatment in people with Tissue Adhesion and Gynecologic Surgery, run by SciVision Biotech Inc. at 1 site in Taiwan.
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 4 inclusion and 6 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 17 Apr 2024. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 incidence of postoperative adhesion at 3 months (time frame: 3 months post-operation). 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 17 Apr 2024.