Tissue Adhesion, Surgery-InducedNCT05058027
Anti-adhesive Effect and Safety of MEDICURTAIN Applied to Undergoing Thyroid Surgery (Pivotal Study)
A study testing GUARDIX-SG® and Medicurtain® in people with Tissue Adhesion, Surgery-Induced, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
This study was designed to demonstrate the non-inferiority of MEDICURTAIN® (investigational device) compared to commercially available GUARDIX-SG® (control device) in treatment of subject who underwent total thyroidectomy for prevention of adhesion formation at 6 weeks after the surgery. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Tissue Adhesion, Surgery-Induced
- What is being tested?
- GUARDIX-SG® and Medicurtain®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jul 2013to 28 Aug 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject (male and female) aged between 20 ~ 65.
- The subject planned a first thyroidectomy for thyroid disease.
- The subject did not have medical history of esophagus-related disease
- The subject was suitable for local anesthesia or general anesthesia (Respiration and Intravenous anesthesia)
- The subject who could communicate with the investigators fluently, understands the purpose of clinical trial and the risk of participation in the clinical trial, and was willing to comply with guideline for clinical trial.
- The subject has been informed of the nature of the study (objective, methodology, efficacy, etc.) and signed written informed consent.
- The subject has been informed the efficacy and risk of anesthesia related to the surgery, procedures and examination, etc. and singed written informed consent.
- The subject who agrees to comply with permitted contraception during the study (example of permitted contraception: using condom and infertility surgery, etc.)
Who cannot join
- The subject had general or local infection.
- The subject was diagnosed with liver and/or kidney and coagulation abnormalities.
- The subject took the prohibited concomitant medication.
- The subject had suppressed immunity or autoimmune disease
- The subject had hypersensitivity to the investigational devices.
- The subject was pregnant of a nursing mother or those who plan pregnancy during the study.
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- The subject had serious disease that may affect to the study justified by Investigators (example: heart failure, kidney failure, pancreatitis, and diabetes, etc.)
- The subjects participate in another investigational study after enrollment of this study or subject previously participated in another investigational study within last 3 months before participating in this study.
- The subject considered to be not eligible to participate in the study justified by Investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ewha Womans University Mokdong Hospital
Seoul, Gangnam-gu, Eonju-ro, 211
About this study
Official title: A Randomized, Multicenter, Subject and Assessor Blind, Parallel, Comparative Non-inferiority Clinical Trial Study to Assess the Anti-adhesive Effect and Safety of MEDICURTAIN® Applied to Undergoing Thyroid Surgery
This study was designed to demonstrate the non-inferiority of MEDICURTAIN® (investigational device) compared to commercially available GUARDIX-SG® (control device) in treatment of subject who underwent total thyroidectomy for prevention of adhesion formation at 6 weeks after the surgery.
Read the detailed description
This clinical trial is a randomized, multi center, subject and evaluator blinded, parallel, comparative and non-inferiority clinical trial study to assess the prevention of adhesion formation in the subjects treated either MEDICURTAIN® or GUARDIX-SG at 6 weeks after total thyroidectomy.
The primary endpoint was defined as abnormal findings of esophageal motility evaluated by the independent third evaluator using marshmallow esophagography. The objective of this study was to demonstrate the non-inferiority of investigational device versus control device for adhesion formation at 6 weeks after the administration of investigational or control devices.
Esophageal motility score and clinical symptoms assessed by the independent third evaluator using marshmallow esophagography at 6 weeks after administration of investigational device were secondary outcome.
- Conditions
- Tissue Adhesion, Surgery-Induced
- Being tested
- GUARDIX-SG®, Medicurtain®
- Keywords
- Medicurtain®, Medicurtain, Anti-adhesion barrier, Sodium hyaluronate
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUARDIX-SG®Device
Also called GUARDIX-SG
GUARDIX-SG® 6g prefilled syringe
Medicurtain®Device
Also called Medicurtain
Medicurtain® 5ml prefilled syringe
| Study group | Role | What they receive |
|---|---|---|
| GUARDIX-SG® | Active comparator | Treat GUARDIX-SG 6g prefilled syringe after surgery Receives: Device: GUARDIX-SG® |
| Medicurtain® | Experimental | Treat Medicurtain® 5ml prefilled syringe after surgery Receives: Device: Medicurtain® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of abnormal findings of esophageal motility evaluated by the independent third evaluator using marshmallow esophagography obtained at 6 weeks after administration of investigational device.
The percentage of abnormal findings measured as mild/moderate/severe in the esophageal motor performance score through marshmallow esophagography is the incidence of adhesion. The esophageal motility was scored as normal 3 point, mild 2 point, moderate 1 point and severe 0 point.
Measured: Week 6
Secondary outcomes (3)
Esophageal motility score assessed by the independent third evaluator using marshmallow esophagography obtained at 6 weeks after administration of investigational device
The esophageal motility was scored as normal 3 point, mild 2 point, moderate 1 point and severe 0 point.
Measured: Week 6
Clinical Symptoms assessed using questionnaire by investigator assessed by using 10 point visual analogue scale (VAS).
The questionnaire is composed of three questions as shown below.
- Discomfort around surgical area
- Discomfort when a patient bends his or her neck backward
- Inflammation reaction and scar formation around surgical area Each item is evaluated in the 10-step evaluation of VAS. 0 = None of pain, 10 = Agonizing.
Measured: Follows up to week 6
Clinical Symptoms assessed using questionnaire by subject assessed by using 10 point visual analogue scale (VAS).
The questionnaire is composed of four questions as shown below.
- Difficulty in swallowing the saliva
- Difficulty in swallowing the water
- Difficulty in swallowing the solid food
- Aesthetic self-satisfaction on the scar around surgical area Each item is evaluated in the 10-step evaluation of VAS. 0 = None of pain, 10 = Agonizing.
Measured: Follows up to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start4 Jul 2013
- Primary completion28 Aug 2014
- Study completion28 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue Adhesion, Surgery-InducedStudies 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byung In Moon, MD, PhD, Principal investigator, Ewha Womans University Mokdong HospitalHang-Seok Chang, MD, PhD, Principal investigator, Gangnam Severance HospitalGil Soo Son, MD, PhD, Principal investigator, Korea UniversitySeung Ki Kim, MD, PhD, Principal investigator, Cha University Bundang Cha Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058027
- Sponsor's protocol ID
- SPMC_0912
- Status last verified
- Sep 2021
- First submitted
- 10 Sep 2021
- Last updated
- 27 Sep 2021
- 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 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Subject and Assessor Blind, Parallel, Comparative Non-inferiority Clinical Trial Study to Assess the Anti-adhesive Effect and Safety of MEDICURTAIN® Applied to Undergoing Thyroid Surgery
- ClinicalTrials.gov ID
- NCT05058027
- Acronym / sponsor ID
- SPMC_0912
- Conditions
- Tissue Adhesion, Surgery-Induced
- Keywords
- Medicurtain®, Medicurtain, Anti-adhesion barrier, Sodium hyaluronate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2013 (actual)
- Primary completion
- 28 Aug 2014 (actual)
- Study completion
- 28 Aug 2014 (actual)
- First posted
- 27 Sep 2021 (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.
This study was designed to demonstrate the non-inferiority of MEDICURTAIN® (investigational device) compared to commercially available GUARDIX-SG® (control device) in treatment of subject who underwent total thyroidectomy for prevention of adhesion formation at 6 weeks after the surgery.
Detailed description
This clinical trial is a randomized, multi center, subject and evaluator blinded, parallel, comparative and non-inferiority clinical trial study to assess the prevention of adhesion formation in the subjects treated either MEDICURTAIN® or GUARDIX-SG at 6 weeks after total thyroidectomy.
The primary endpoint was defined as abnormal findings of esophageal motility evaluated by the independent third evaluator using marshmallow esophagography. The objective of this study was to demonstrate the non-inferiority of investigational device versus control device for adhesion formation at 6 weeks after the administration of investigational or control devices.
Esophageal motility score and clinical symptoms assessed by the independent third evaluator using marshmallow esophagography at 6 weeks after administration of investigational device were secondary outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GUARDIX-SG® | Active comparator | Device: GUARDIX-SG®Treat GUARDIX-SG 6g prefilled syringe after surgery |
| Medicurtain® | Experimental | Device: Medicurtain®Treat Medicurtain® 5ml prefilled syringe after surgery |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject (male and female) aged between 20 ~ 65.
- The subject planned a first thyroidectomy for thyroid disease.
- The subject did not have medical history of esophagus-related disease
- The subject was suitable for local anesthesia or general anesthesia (Respiration and Intravenous anesthesia)
- The subject who could communicate with the investigators fluently, understands the purpose of clinical trial and the risk of participation in the clinical trial, and was willing to comply with guideline for clinical trial.
Key exclusion criteria (9 listed)
- The subject had general or local infection.
- The subject was diagnosed with liver and/or kidney and coagulation abnormalities.
- The subject took the prohibited concomitant medication.
- The subject had suppressed immunity or autoimmune disease
- The subject had hypersensitivity to the investigational devices.
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 |
|---|---|---|
| GUARDIX-SG®Also: GUARDIX-SGGUARDIX-SG® 6g prefilled syringe | Device | GUARDIX-SG® |
| Medicurtain®Also: MedicurtainMedicurtain® 5ml prefilled syringe | Device | Medicurtain® |
Primary outcome
Presence of abnormal findings of esophageal motility evaluated by the independent third evaluator using marshmallow esophagography obtained at 6 weeks after administration of investigational device.
Time frame: Week 6
The percentage of abnormal findings measured as mild/moderate/severe in the esophageal motor performance score through marshmallow esophagography is the incidence of adhesion. The esophageal motility was scored as normal 3 point, mild 2 point, moderate 1 point and severe 0 point.
3 secondary outcomes
Esophageal motility score assessed by the independent third evaluator using marshmallow esophagography obtained at 6 weeks after administration of investigational device
Time frame: Week 6
Clinical Symptoms assessed using questionnaire by investigator assessed by using 10 point visual analogue scale (VAS).
Time frame: Follows up to week 6
Clinical Symptoms assessed using questionnaire by subject assessed by using 10 point visual analogue scale (VAS).
Time frame: Follows up to week 6
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 27 Sep 2021.
- 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.
Byung In Moon, MD, PhD principal investigator
Ewha Womans University Mokdong Hospital
Hang-Seok Chang, MD, PhD principal investigator
Gangnam Severance Hospital
Gil Soo Son, MD, PhD principal investigator
Korea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GUARDIX-SG® and Medicurtain® in people with Tissue Adhesion, Surgery-Induced, run by Shin Poong Pharmaceutical Co. Ltd. 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 8 inclusion and 9 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 27 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 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?
Presence of abnormal findings of esophageal motility evaluated by the independent third evaluator using marshmallow esophagography obtained at 6 weeks after administration of investigational device. (time frame: Week 6). 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 27 Sep 2021.