Gastrointestinal BleedingNCT07727564
A Disposable Endoscopic Closing Device Used for the Closure of Gastrointestinal Tissue
A study testing disposable endoscopic closing device and metal clips, or metal clips in combination with nylon loops in people with Gastrointestinal Bleeding and Gastrointestinal Neoplasms, run by Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Trial summary
This clinical trial employs a prospective, multicenter, randomized, single-blind, parallel-controlled, non-inferiority design with a positive comparator device. The study aims to assess the safety and efficacy of the disposable endoscopic closing device manufactured by Jiangsu Vedkang Medical Science and Technology… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Bleeding, Gastrointestinal Neoplasms
- What is being tested?
- disposable endoscopic closing device and metal clips, or metal clips in combination with nylon loops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- No restrictions on gender or race.
- Intraoperative endoscopic confirmation of gastrointestinal tissue defects or lesions (≤50 mm) requiring closure, such as post-endoscopic resection mucosal defects, gastrointestinal fistulas, active bleeding, gastrointestinal perforation, colonic diverticular bleeding, etc.
- The local anatomy, tissue thickness, and inflammatory status of the target lesion and its surrounding tissues are assessed by the endoscopist as sufficient to withstand the mechanical tensile and anchoring forces exerted by the device (screws or clips).
- Patients possess good communication skills and compliance, are willing to cooperate in completing a 30-day clinical follow-up observation, and have an expected survival of more than 6 months.
- Voluntary participation in this clinical trial, with written informed consent approved by the Ethics Committee signed by the patient or their legally authorized representative.
Who cannot join
- Presence of severe coagulation disorders, specifically defined as: platelet count < 50 × 10⁹/L, or international normalized ratio (INR) > 2.0, or partial thromboplastin time (PTT) > 2× the upper limit of normal, and not correctable by blood product transfusion or medication prior to the procedure.
- Concomitant high-risk conditions such as severe organ dysfunction, including: severe hepatic or renal insufficiency (AST or ALT > 3× upper limit of normal; serum creatinine > 3× upper limit of normal), heart failure classified as NYHA Class III-IV, or presence of impaired consciousness, or profound hemorrhagic shock (systolic blood pressure < 90 mmHg and heart rate > 110 bpm) without successful resuscitation.
- Continuous use of systemic anticoagulants (e.g., warfarin, novel oral anticoagulants) or dual antiplatelet agents within 7 days prior to the procedure (with the exception of aspirin monotherapy), and inability to safely discontinue or implement bridging therapy before and after the procedure.
- Known allergy to medical-grade surgical stainless steel (containing metallic components such as nickel, cobalt, chromium), polypropylene polymeric materials, or anesthetic/sedative medications required for endoscopic procedures.
- Female patients who are pregnant or breastfeeding.
- Current participation in another drug or medical device clinical trial, with less than 30 days having elapsed since the last withdrawal from the previous trial, or presence of any other factors that, in the investigator's opinion, may interfere with the evaluation of trial outcomes.
- Conditions deemed by the investigator as inappropriate for the patient's enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Disposable Endoscopic Closing Device Used for the Closure of Gastrointestinal Tissue: a Prospective, Multicenter, Randomized Controlled Clinical Trial
This clinical trial employs a prospective, multicenter, randomized, single-blind, parallel-controlled, non-inferiority design with a positive comparator device. The study aims to assess the safety and efficacy of the disposable endoscopic closing device manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd. when applied for gastrointestinal tissue closing and hemostasis.
The trial group will undergo closure and hemostasis using disposable endoscopic closing device.
Read more
The control group will undergo closure and hemostasis using metal clips, or metal clips in combination with nylon loops.
This device is clinically indicated for patients requiring closure of gastrointestinal tissue.
Primary effectiveness endpoint: composite clinical success rate. Secondary effectiveness endpoints: endoscopic procedure time. Secondary safety endpoints: incidence of adverse events, incidence of serious adverse events, and incidence of device malfunctions.
Vital signs and hemoglobin changes will be closely monitored during the 24-hour period following the procedure. At 7 days postoperatively, a follow-up assessment (either outpatient or by telephone) will be performed. At 30 days postoperatively, the final outpatient follow-up visit will be conducted.
- Being tested
- disposable endoscopic closing device, metal clips, or metal clips in combination with nylon loops
- Medical subject headings
- Gastrointestinal Hemorrhage, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disposable endoscopic closing deviceDevice
Using disposable endoscopic closing device to closure and hemostasis
metal clips, or metal clips in combination with nylon loopsDevice
Using metal clips, or metal clips in combination with nylon loops to closure and hemostasis
| Study group | Role | What they receive |
|---|---|---|
| Using disposable endoscopic closing device to closure and hemostasis | Experimental | Not described Receives: Device: disposable endoscopic closing device |
| Using metal clips, or metal clips in combination with nylon loops to closure and hemostasis | Active comparator | Not described Receives: Device: metal clips, or metal clips in combination with nylon loops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness : composite clinical success rate. Composite clinical success = Technical success AND 7-day post-procedural clinical success AND 30-day post-procedural clinical success.
Technical success is defined as the successful achievement of complete closure of the target lesion or immediate hemostasis following a single application of the randomly assigned investigational or control device during the initial endoscopic procedure, without the need for any unassigned adjunctive closure devices not originally allocated.
7-day post-procedural clinical successis defined as the absence of any clinically significant delayed bleeding event occurring from the completion of the initial endoscopic procedure up to post-operative day 7 (±1 day).
30-day post-procedural clinical success is defined as the patient concurrently meeting all of the following criteria from the completion of the initial endoscopic procedure up to post-operative day 30 (±3 days):
- Absence of clinically significant delayed bleeding
- Absence of perforation
- Absence of salvage interventions
- Absence of attributable mortality
Measured: 30 days
Secondary outcomes (4)
Endoscopic procedure time.
Measured: 2 hours
Adverse Event Rate
Measured: 30 days
Serious Adverse Event Rate
Measured: 30 days
Device Malfunction Rate
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal BleedingStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Vedkang Medical Science and Technology Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727564
- Sponsor's protocol ID
- VDKPF-HCD-046
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Disposable Endoscopic Closing Device Used for the Closure of Gastrointestinal Tissue: a Prospective, Multicenter, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07727564
- Acronym / sponsor ID
- VDKPF-HCD-046
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu Vedkang Medical Science and Technology Co., LtdUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 27 Jul 2026 (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 clinical trial employs a prospective, multicenter, randomized, single-blind, parallel-controlled, non-inferiority design with a positive comparator device. The study aims to assess the safety and efficacy of the disposable endoscopic closing device manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd. when applied for gastrointestinal tissue closing and hemostasis.
The trial group will undergo closure and hemostasis using disposable endoscopic closing device.
The control group will undergo closure and hemostasis using metal clips, or metal clips in combination with nylon loops.
This device is clinically indicated for patients requiring closure of gastrointestinal tissue.
Primary effectiveness endpoint: composite clinical success rate. Secondary effectiveness endpoints: endoscopic procedure time. Secondary safety endpoints: incidence of adverse events, incidence of serious adverse events, and incidence of device malfunctions.
Vital signs and hemoglobin changes will be closely monitored during the 24-hour period following the procedure. At 7 days postoperatively, a follow-up assessment (either outpatient or by telephone) will be performed. At 30 days postoperatively, the final outpatient follow-up visit will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using disposable endoscopic closing device to closure and hemostasis | Experimental | Device: disposable endoscopic closing device |
| Using metal clips, or metal clips in combination with nylon loops to closure and hemostasis | Active comparator | Device: metal clips, or metal clips in combination with nylon loops |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- No restrictions on gender or race.
- Intraoperative endoscopic confirmation of gastrointestinal tissue defects or lesions (≤50 mm) requiring closure, such as post-endoscopic resection mucosal defects, gastrointestinal fistulas, active bleeding, gastrointestinal perforation, colonic diverticular bleeding, etc.
- The local anatomy, tissue thickness, and inflammatory status of the target lesion and its surrounding tissues are assessed by the endoscopist as sufficient to withstand the mechanical tensile and anchoring forces exerted by the device (screws or clips).
- Patients possess good communication skills and compliance, are willing to cooperate in completing a 30-day clinical follow-up observation, and have an expected survival of more than 6 months.
- Voluntary participation in this clinical trial, with written informed consent approved by the Ethics Committee signed by the patient or their legally authorized representative.
Key exclusion criteria (7 listed)
- Presence of severe coagulation disorders, specifically defined as: platelet count < 50 × 10⁹/L, or international normalized ratio (INR) > 2.0, or partial thromboplastin time (PTT) > 2× the upper limit of normal, and not correctable by blood product transfusion or medication prior to the procedure.
- Concomitant high-risk conditions such as severe organ dysfunction, including: severe hepatic or renal insufficiency (AST or ALT > 3× upper limit of normal; serum creatinine > 3× upper limit of normal), heart failure classified as NYHA Class III-IV, or presence of impaired consciousness, or profound hemorrhagic shock (systolic blood pressure < 90 mmHg and heart rate > 110 bpm) without successful resuscitation.
- Continuous use of systemic anticoagulants (e.g., warfarin, novel oral anticoagulants) or dual antiplatelet agents within 7 days prior to the procedure (with the exception of aspirin monotherapy), and inability to safely discontinue or implement bridging therapy before and after the procedure.
- Known allergy to medical-grade surgical stainless steel (containing metallic components such as nickel, cobalt, chromium), polypropylene polymeric materials, or anesthetic/sedative medications required for endoscopic procedures.
- Female patients who are pregnant or breastfeeding.
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 |
|---|---|---|
| disposable endoscopic closing deviceUsing disposable endoscopic closing device to closure and hemostasis | Device | Using disposable endoscopic closing device to closure and hemostasis |
| metal clips, or metal clips in combination with nylon loopsUsing metal clips, or metal clips in combination with nylon loops to closure and hemostasis | Device | Using metal clips, or metal clips in combination with nylon loops to closure and hemostasis |
Primary outcome
Effectiveness : composite clinical success rate. Composite clinical success = Technical success AND 7-day post-procedural clinical success AND 30-day post-procedural clinical success.
Time frame: 30 days
Technical success is defined as the successful achievement of complete closure of the target lesion or immediate hemostasis following a single application of the randomly assigned investigational or control device during the initial endoscopic procedure, without the need for any unassigned adjunctive closure devices not originally allocated. 7-day post-procedural clinical successis defined as the absence of any clinically significant delayed bleeding event occurring from the completion of the initial endoscopic procedure up to post-operative day 7 (±1 day). 30-day post-procedural clinical success is defined as the patient concurrently meeting all of the following criteria from the completion of the initial endoscopic procedure up to post-operative day 30 (±3 days): 1. Absence of clinically significant delayed bleeding 2. Absence of perforation 3. Absence of salvage interventions 4. Absence of attributable mortality
4 secondary outcomes
Endoscopic procedure time.
Time frame: 2 hours
Adverse Event Rate
Time frame: 30 days
Serious Adverse Event Rate
Time frame: 30 days
Device Malfunction Rate
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing disposable endoscopic closing device and metal clips, or metal clips in combination with nylon loops in people with Gastrointestinal Bleeding and Gastrointestinal Neoplasms, run by Jiangsu Vedkang Medical Science and Technology Co., Ltd.
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 7 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: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (+86 15161150617, hongjun.shao@vedkang.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness : composite clinical success rate. Composite clinical success = Technical success AND 7-day post-procedural clinical success AND 30-day post-procedural clinical success. (time frame: 30 days). 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 Jul 2026.