Inguinal HerniaNCT02487628
Evaluation of HQ® Matrix Soft Tissue Mesh for the Treatment of Inguinal Hernia
A study testing HQ® Matrix Soft Tissue Mesh and ULTRAPRO® Partially Absorbable Lightweight Mesh in people with Inguinal Hernia, run by Zhejiang Xingyue Biotechnology Co., Ltd. at 7 sites in China.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Soft Tissue Mesh for the Treatment of Inguinal Hernia. Half of participants will receive HQ® Matrix Soft Tissue Mesh, while the other half will receive ULTRAPRO® Partially Absorbable Lightweight Mesh. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- HQ® Matrix Soft Tissue Mesh and ULTRAPRO® Partially Absorbable Lightweight Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 7 sitesChina
- Study dates
- Nov 2014to Dec 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed clinically as inguinal hernia;
- Need to be treated with open tension-free hernioplasty;
- BMI ≤ 40 kg/m^2;
- Aged from 18 - 70, male or female;
- The patients voluntarily signed the subjects' informed consent form.
Who cannot join
- Surgeries that cut the gastrointestinal tract or the gastrointestinal tract ruptures accidently;
- Surgeries that repair the inguinal hernia intraperitoneally;
- Patients that have done the hernioplasty earlier and undergone multiple recurrence (recurrence rate ≥ 2);
- The surgical wounds are contaminated;
- Patients that are treated with coagulant;
- Patients with serious complication;
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- Patients with pregnancy or lactation;
- Patients with mental disease including serious hysteria.Do not have legal capacity or have restricted capacity;
- Those allergic to the test products;
- Patients that participated other clinical trials in the last 3 months;
- Patients who, according to other doctors' opinion, are unsuitable to use this material for the treatment.
Trial locations and contacts
7 sites in 1 country.
Yongxu Yang contact
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
The Forth Hospital of Changsha
Changsha, Hunan, 410006
Guohuang Hu, +86-13908452960
- Recruiting
Xiangya Hospital of Centre-South University
Changsha, Hunan, 410008
Jianhua Huang, +86-13507319258
- Recruiting
Huanggang Central Hospital
Huanggang, Hubei, 438000
Youneng Yuan, +86-15971530385
- Recruiting
Huangshi Central Hospital
Huangshi, Hubei, 435000
Youneng Yuan, 15971530385
- Recruiting
Taian Chinese Medicine Hospital
Taian, Shandong
Yuejie Chen, +86-18653891638
- Recruiting
Xiangtan Central Hospital
Xiangtan, Hunan
Shaojie Li, +86-13327320903
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
Dejie Chen, +86-13995743892
About this study
Official title: Multi-center, Randomized, Active-controlled, Single-blind, Parallel Two-group Trial of HQ® Matrix Soft Tissue Mesh and ULTRAPRO® Partially Absorbable Lightweight Mesh for the Treatment of Inguinal Hernia
The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Soft Tissue Mesh for the Treatment of Inguinal Hernia. Half of participants will receive HQ® Matrix Soft Tissue Mesh, while the other half will receive ULTRAPRO® Partially Absorbable Lightweight Mesh.
Read the detailed description
HQ® Matrix Soft Tissue Mesh is a warp-knitted, multifilament, bioengineered scaffold which is comprised of the silk fibroin protein of the Bombyx mori (B. mori) silkworm. The porous network structure makes it soft and pliable and convenient to implant. The mesh is mechanically strong, biocompatible, and long-term bioresorbable. The pore size is suitable for macrophage migration and recruitment, which hinders bacteria growth. The mesh is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application. It is sterile and for single-patient use only.
ULTRAPRO® Partially Absorbable Lightweight Mesh (Ethicon, Inc.) is manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non-absorbable polypropylene monofilament fiber. Designed for open and laparoscopic hernia repairs, it allows surgeons the versatility to perform various hernia repairs with a single technology. It offers excellent strength with minimal foreign body mass, to allow patients to heal more naturally with increased comfort and mobility.
- Conditions
- Inguinal Hernia
- Being tested
- HQ® Matrix Soft Tissue Mesh, ULTRAPRO® Partially Absorbable Lightweight Mesh
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HQ® Matrix Soft Tissue MeshDevice
Also called HQ® Matrix
ULTRAPRO® Partially Absorbable Lightweight MeshDevice
Also called ULTRAPRO®
| Study group | Role | What they receive |
|---|---|---|
| HQ® Matrix Soft Tissue Mesh | Experimental | HQ® Matrix Soft Tissue Mesh is a warp-knitted, multifilament, bioengineered scaffold which is comprised of the silk fibroin protein of the Bombyx mori (B. mori) silkworm. The porous network structure makes it soft and pliable and convenient to implant. The mesh is mechanically strong, biocompatible, and long-term bioresorbable. The pore size is suitable for macrophage migration and recruitment, which hinders bacteria growth. The mesh is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application. It is sterile and for single-patient use only. Receives: Device: HQ® Matrix Soft Tissue Mesh |
| ULTRAPRO® Partially Absorbable Lightweight Mesh | Active comparator | ULTRAPRO® Partially Absorbable Lightweight Mesh (Ethicon, Inc.) is manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non-absorbable polypropylene monofilament fiber. Designed for open and laparoscopic hernia repairs, it allows surgeons the versatility to perform various hernia repairs with a single technology. It offers excellent strength with minimal foreign body mass, to allow patients to heal more naturally with increased comfort and mobility. Receives: Device: ULTRAPRO® Partially Absorbable Lightweight Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative recurrent rate
Measured: Day 1 post-operation
Postoperative recurrent rate
Measured: Day 3 post-operation
Postoperative recurrent rate
Measured: 1 day before hospital discharge
Postoperative recurrent rate
Measured: 6 months ± 14 days post-operation
Secondary outcomes (4)
Number of Participants with Postoperative Complications
Measured: Day 1 and day 3 post-operation, 1 day before hospital discharge, and 6 months ± 14 days post-operation
Number of Participants with Discomfort
Measured: Day 1 and day 3 post-operation, 1 day before hospital discharge, and 6 months ± 14 days post-operation
Number of Participants with Foreign Body Sensation
Measured: Day 1 and day 3 post-operation, 1 day before hospital discharge, and 6 months ± 14 days post-operation
The average hospitalization time
Measured: 1 day before hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startNov 2014
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Xingyue Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianhua Huang, Principal investigator, Xiangya Hospital of Centre-South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487628
- Sponsor's protocol ID
- YL-QX-YYZZBP-2014
- Status last verified
- Jun 2015
- First submitted
- 26 Jun 2015
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Active-controlled, Single-blind, Parallel Two-group Trial of HQ® Matrix Soft Tissue Mesh and ULTRAPRO® Partially Absorbable Lightweight Mesh for the Treatment of Inguinal Hernia
- ClinicalTrials.gov ID
- NCT02487628
- Acronym / sponsor ID
- YL-QX-YYZZBP-2014
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Zhejiang Xingyue Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Jul 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.
The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Soft Tissue Mesh for the Treatment of Inguinal Hernia. Half of participants will receive HQ® Matrix Soft Tissue Mesh, while the other half will receive ULTRAPRO® Partially Absorbable Lightweight Mesh.
Detailed description
HQ® Matrix Soft Tissue Mesh is a warp-knitted, multifilament, bioengineered scaffold which is comprised of the silk fibroin protein of the Bombyx mori (B. mori) silkworm. The porous network structure makes it soft and pliable and convenient to implant. The mesh is mechanically strong, biocompatible, and long-term bioresorbable. The pore size is suitable for macrophage migration and recruitment, which hinders bacteria growth. The mesh is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application. It is sterile and for single-patient use only.
ULTRAPRO® Partially Absorbable Lightweight Mesh (Ethicon, Inc.) is manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non-absorbable polypropylene monofilament fiber. Designed for open and laparoscopic hernia repairs, it allows surgeons the versatility to perform various hernia repairs with a single technology. It offers excellent strength with minimal foreign body mass, to allow patients to heal more naturally with increased comfort and mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HQ® Matrix Soft Tissue Mesh | Experimental | Device: HQ® Matrix Soft Tissue MeshHQ® Matrix Soft Tissue Mesh is a warp-knitted, multifilament, bioengineered scaffold which is comprised of the silk fibroin protein of the Bombyx mori (B. mori) silkworm. The porous network structure makes it soft and pliable and convenient to implant. The mesh is mechanically strong, biocompatible, and long-term bioresorbable. The pore size is suitable for macrophage migration and recruitment, which hinders bacteria growth. The mesh is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application. It is sterile and for single-patient use only. |
| ULTRAPRO® Partially Absorbable Lightweight Mesh | Active comparator | Device: ULTRAPRO® Partially Absorbable Lightweight MeshULTRAPRO® Partially Absorbable Lightweight Mesh (Ethicon, Inc.) is manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non-absorbable polypropylene monofilament fiber. Designed for open and laparoscopic hernia repairs, it allows surgeons the versatility to perform various hernia repairs with a single technology. It offers excellent strength with minimal foreign body mass, to allow patients to heal more naturally with increased comfort and mobility. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed clinically as inguinal hernia;
- Need to be treated with open tension-free hernioplasty;
- BMI ≤ 40 kg/m^2;
- Aged from 18 - 70, male or female;
- The patients voluntarily signed the subjects' informed consent form.
Key exclusion criteria (11 listed)
- Surgeries that cut the gastrointestinal tract or the gastrointestinal tract ruptures accidently;
- Surgeries that repair the inguinal hernia intraperitoneally;
- Patients that have done the hernioplasty earlier and undergone multiple recurrence (recurrence rate ≥ 2);
- The surgical wounds are contaminated;
- Patients that are treated with coagulant;
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 |
|---|---|---|
| HQ® Matrix Soft Tissue MeshAlso: HQ® Matrix | Device | HQ® Matrix Soft Tissue Mesh |
| ULTRAPRO® Partially Absorbable Lightweight MeshAlso: ULTRAPRO® | Device | ULTRAPRO® Partially Absorbable Lightweight Mesh |
Primary outcome
Postoperative recurrent rate
Time frame: Day 1 post-operation
Postoperative recurrent rate
Time frame: Day 3 post-operation
Postoperative recurrent rate
Time frame: 1 day before hospital discharge
Postoperative recurrent rate
Time frame: 6 months ± 14 days post-operation
4 secondary outcomes
Number of Participants with Postoperative Complications
Time frame: Day 1 and day 3 post-operation, 1 day before hospital discharge, and 6 months ± 14 days post-operation
Number of Participants with Discomfort
Time frame: Day 1 and day 3 post-operation, 1 day before hospital discharge, and 6 months ± 14 days post-operation
Number of Participants with Foreign Body Sensation
Time frame: Day 1 and day 3 post-operation, 1 day before hospital discharge, and 6 months ± 14 days post-operation
The average hospitalization time
Time frame: 1 day before hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
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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.
Yongxu Yang contact
Jianhua Huang principal investigator
Xiangya Hospital of Centre-South University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HQ® Matrix Soft Tissue Mesh and ULTRAPRO® Partially Absorbable Lightweight Mesh in people with Inguinal Hernia, run by Zhejiang Xingyue Biotechnology Co., Ltd. at 7 sites in China.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongxu Yang (+86-13488696229), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative recurrent rate (time frame: Day 1 post-operation). The study lists 4 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 Jul 2015.