GIST - Gastrointestinal Stromal TumorNCT07581977
A Novel Two-Tooth Clip for ESD and EFTR of GIST
A study testing A Novel Two-Tooth Endoscopic Clip and Clip in people with GIST - Gastrointestinal Stromal Tumor, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
This study is designed to evaluate the efficacy and safety of a novel two-tooth endoscopic clip, utilized in a "clip with line" traction configuration, during endoscopic resection procedures (ESD and EFTR) of GIST. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- GIST - Gastrointestinal Stromal Tumor
- What is being tested?
- A Novel Two-Tooth Endoscopic Clip and Clip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2026to 1 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 85 years.
- Patients diagnosed with gastric gastrointestinal lesions clinically indicated for ESD or EFTR.
- Lesion size between 2 cm and 5 cm in diameter.
- Willing and able to provide written informed consent.
Who cannot join
- Lesions with clear evidence of deep submucosal invasion or distant metastasis precluding curative endoscopic resection.
- Severe coagulation dysfunction (international normalized ratio >2.0, platelet count <50,000/µL) or ongoing use of dual antiplatelet therapy/anticoagulants that cannot be appropriately bridged or discontinued per guidelines.
- Severe organ failure (cardiac, renal, hepatic, or respiratory) rendering the patient unsuitable for prolonged sedation or general anesthesia.
- Pregnancy or lactation.
- Prior surgical or endoscopic intervention at the target lesion site that results in significant fibrosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, 100071
About this study
Official title: Efficacy and Safety of a Novel Two-Tooth Clip-Assisted ESD and EFTR of GIST: A Single-Center, Prospective, Open-Label, Randomized Controlled Study
This study is designed to evaluate the efficacy and safety of a novel two-tooth endoscopic clip, utilized in a "clip with line" traction configuration, during endoscopic resection procedures (ESD and EFTR) of GIST. The novel clip's dual-tooth design is intended to provide a more secure anchor on the lesion, enabling effective counter-traction when combined with a line. The primary aim is to determine if this method improves submucosal dissection efficiency compared to conventional ESD. A secondary aim is to evaluate the performance of the same clip system for full-thickness or mucosal defect closure.
Read the detailed description
Endoscopic Submucosal Dissection (ESD) and Endoscopic Full-Thickness Resection (EFTR) are established, minimally invasive techniques for the en-bloc resection of gastrointestinal stromal tumor (GIST). However, a persistent challenge, especially in difficult locations or large lesions, is the lack of sufficient counter-traction, which leads to prolonged procedure times, increased risk of intraoperative bleeding, and potential for incomplete resection due to poor visualization of the submucosal layer. Furthermore, managing large post resection defects or perforations requires reliable and technically feasible endoscopic suturing.
This study introduces a novel two-tooth clip. The device's geometry is hypothesized to provide a stronger, more stable grasp on the targeted tissue compared to standard single-tooth or non-toothed clips. The study will investigate two sequential applications of this clip within a single procedure:
The Traction Phase: A "clip with line" technique will be employed. The novel two-tooth clip will be anchored to the proximal edge of the lesion. A dental line, pre-tied to the clip, will be used by the endoscopist to apply adjustable counter-traction. This is intended to lift the lesion, tauten the submucosal fibers, and clearly expose the dissection plane, thereby simulating the principle of surgical counter-traction.
The Closure Phase: Following lesion resection, the novel two-tooth clip will be utilized to perform a continuous, circumferential closure of the mucosal defect or perforation. The study will assess the technical success rate, time required for complete closure, and the clip's ability to securely approximate tissue layers.
- Conditions
- GIST - Gastrointestinal Stromal Tumor
- Being tested
- A Novel Two-Tooth Endoscopic Clip, Clip
- Keywords
- GIST, ESD, EFTR, two-tooth clips
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Novel Two-Tooth Endoscopic ClipDevice
"Clip with line" traction method with the novel two-tooth clip will be applied in patients undergoing ESD or EFTR. After lesion retrieval, defects requiring closure will be managed using the same novel two-tooth clips.
ClipDevice
Standard ESD or EFTR without the use of dedicated traction devices will be performed, then using the standard clips for closure.
| Study group | Role | What they receive |
|---|---|---|
| Novel Clip-Assisted Traction ESD/EFTR | Experimental | Patients will undergo ESD or EFTR using the "clip with line" traction method with the novel two-tooth clip. After initial circumferential mucosal incision, the two-tooth clip (with pre-tied line) will be anchored to the lesion. The endoscopist will apply continuous or intermittent traction via the line to optimize the submucosal view. After lesion retrieval, defects requiring closure will be managed using the same novel two-tooth clips in a purse-string configuration. Receives: Device: A Novel Two-Tooth Endoscopic Clip |
| Conventional ESD/EFTR | Active comparator | Patients will undergo standard ESD or EFTR without the use of dedicated traction devices. The endoscopist may use transparent cap assistance and positional changes for exposure, which is current standard practice. Receives: Device: Clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Submucosal Dissection Efficiency
The rate of submucosal dissection (measured in mm²/min), calculated from the start of submucosal entry to the completion of lesion removal.
Measured: 24 hours
Secondary outcomes (4)
Technical Success Rate of Purse-String Closure
Percentage of cases where complete, circumferential mucosal/full-thickness defect closure is achieved using the novel two-tooth clip without conversion to alternative closure devices.
Measured: 24 hours
Incidence of Intraoperative Adverse Events
- Rates of immediate perforation (unintended) in both groups during the dissection phase
- Rates of significant active bleeding requiring emergency hemostasis (aside from planned vessel coagulation) in both groups during the dissection phase
- Rates of muscularis injury in both groups during the dissection phase
Measured: 3 days
Defect Closure Time
Time taken to achieve complete purse-string closure of the post-resection defect.
Measured: 24 hours
Post-procedural Outcomes
- Rates of delayed bleeding within 90 days
- Rates of delayed perforation within 90 days
- Rates of post-polypectomy electrocoagulation syndrome within 90 days
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start24 Apr 2026
- Primary completion24 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GIST - Gastrointestinal Stromal TumorStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Liu, M.D.,Ph.D., Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581977
- Sponsor's protocol ID
- TTC-GIST
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang K, Hu S, Zhang X, Min M, Liu Y. The retained-bridge traction strategy: a novel solution for secure defect closure following duodenal endoscopic full-thickness resection. Endoscopy. 2026 Mar;58(S 01):E374-E375. doi: 10.1055/a-2804-6504. Epub 2026 Mar 9. No abstract available.
PubMed 41802768Hu S, Chu J, Qiao Y, Shen W, Tang A, Zhang H, Zhang X, Min M, Liu Y. A novel enhanced two-tooth clip for reliable defect closure endoscopically: An ex vivo comparative and in vivo feasibility study. Surg Endosc. 2026 Jan;40(1):864-874. doi: 10.1007/s00464-025-12450-5. Epub 2025 Dec 12.
PubMed 41388104Qiao Y, Hu S, Shen W, Tang A, Zhang X, Zhang H, Min M, Liu Y. Novel endoscopic gastric purse-string suture device for weight management in a porcine model (with video). Endosc Int Open. 2025 Apr 15;13:a25399167. doi: 10.1055/a-2539-9167. eCollection 2025.
PubMed 40309063Hu S, Qiao Y, Zhang X, Min M, Liu Y. Transrectal endoscopic resection of intraperitoneal gastrointestinal stromal tumor facilitated by incidental segmental absence of intestinal musculature. Endoscopy. 2025 Dec;57(S 01):E945-E946. doi: 10.1055/a-2665-7697. Epub 2025 Aug 20. No abstract available.
PubMed 40834899
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Novel Two-Tooth Clip-Assisted ESD and EFTR of GIST: A Single-Center, Prospective, Open-Label, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07581977
- Acronym / sponsor ID
- TTC-GIST
- Conditions
- GIST - Gastrointestinal Stromal Tumor
- Keywords
- GIST, ESD, EFTR, two-tooth clips
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 24 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 12 May 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 study is designed to evaluate the efficacy and safety of a novel two-tooth endoscopic clip, utilized in a "clip with line" traction configuration, during endoscopic resection procedures (ESD and EFTR) of GIST. The novel clip's dual-tooth design is intended to provide a more secure anchor on the lesion, enabling effective counter-traction when combined with a line. The primary aim is to determine if this method improves submucosal dissection efficiency compared to conventional ESD. A secondary aim is to evaluate the performance of the same clip system for full-thickness or mucosal defect closure.
Detailed description
Endoscopic Submucosal Dissection (ESD) and Endoscopic Full-Thickness Resection (EFTR) are established, minimally invasive techniques for the en-bloc resection of gastrointestinal stromal tumor (GIST). However, a persistent challenge, especially in difficult locations or large lesions, is the lack of sufficient counter-traction, which leads to prolonged procedure times, increased risk of intraoperative bleeding, and potential for incomplete resection due to poor visualization of the submucosal layer. Furthermore, managing large post resection defects or perforations requires reliable and technically feasible endoscopic suturing.
This study introduces a novel two-tooth clip. The device's geometry is hypothesized to provide a stronger, more stable grasp on the targeted tissue compared to standard single-tooth or non-toothed clips. The study will investigate two sequential applications of this clip within a single procedure:
The Traction Phase: A "clip with line" technique will be employed. The novel two-tooth clip will be anchored to the proximal edge of the lesion. A dental line, pre-tied to the clip, will be used by the endoscopist to apply adjustable counter-traction. This is intended to lift the lesion, tauten the submucosal fibers, and clearly expose the dissection plane, thereby simulating the principle of surgical counter-traction.
The Closure Phase: Following lesion resection, the novel two-tooth clip will be utilized to perform a continuous, circumferential closure of the mucosal defect or perforation. The study will assess the technical success rate, time required for complete closure, and the clip's ability to securely approximate tissue layers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel Clip-Assisted Traction ESD/EFTR | Experimental | Device: A Novel Two-Tooth Endoscopic ClipPatients will undergo ESD or EFTR using the "clip with line" traction method with the novel two-tooth clip. After initial circumferential mucosal incision, the two-tooth clip (with pre-tied line) will be anchored to the lesion. The endoscopist will apply continuous or intermittent traction via the line to optimize the submucosal view. After lesion retrieval, defects requiring closure will be managed using the same novel two-tooth clips in a purse-string configuration. |
| Conventional ESD/EFTR | Active comparator | Device: ClipPatients will undergo standard ESD or EFTR without the use of dedicated traction devices. The endoscopist may use transparent cap assistance and positional changes for exposure, which is current standard practice. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 85 years.
- Patients diagnosed with gastric gastrointestinal lesions clinically indicated for ESD or EFTR.
- Lesion size between 2 cm and 5 cm in diameter.
- Willing and able to provide written informed consent.
Key exclusion criteria (5 listed)
- Lesions with clear evidence of deep submucosal invasion or distant metastasis precluding curative endoscopic resection.
- Severe coagulation dysfunction (international normalized ratio >2.0, platelet count <50,000/µL) or ongoing use of dual antiplatelet therapy/anticoagulants that cannot be appropriately bridged or discontinued per guidelines.
- Severe organ failure (cardiac, renal, hepatic, or respiratory) rendering the patient unsuitable for prolonged sedation or general anesthesia.
- Pregnancy or lactation.
- Prior surgical or endoscopic intervention at the target lesion site that results in significant fibrosis.
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 |
|---|---|---|
| A Novel Two-Tooth Endoscopic Clip"Clip with line" traction method with the novel two-tooth clip will be applied in patients undergoing ESD or EFTR. After lesion retrieval, defects requiring closure will be managed using the same novel two-tooth clips. | Device | Novel Clip-Assisted Traction ESD/EFTR |
| ClipStandard ESD or EFTR without the use of dedicated traction devices will be performed, then using the standard clips for closure. | Device | Conventional ESD/EFTR |
Primary outcome
Submucosal Dissection Efficiency
Time frame: 24 hours
The rate of submucosal dissection (measured in mm²/min), calculated from the start of submucosal entry to the completion of lesion removal.
4 secondary outcomes
Technical Success Rate of Purse-String Closure
Time frame: 24 hours
Incidence of Intraoperative Adverse Events
Time frame: 3 days
Defect Closure Time
Time frame: 24 hours
Post-procedural Outcomes
Time frame: 3 months
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 22 May 2026.
- Background: PubMed 41802768Zhang K, Hu S, Zhang X, Min M, Liu Y. The retained-bridge traction strategy: a novel solution for secure defect closure following duodenal endoscopic full-thickness resection. Endoscopy. 2026 Mar;58(S 01):E374-E375. doi: 10.1055/a-2804-6504. Epub 2026 Mar 9. No abstract available.
- Background: PubMed 41388104Hu S, Chu J, Qiao Y, Shen W, Tang A, Zhang H, Zhang X, Min M, Liu Y. A novel enhanced two-tooth clip for reliable defect closure endoscopically: An ex vivo comparative and in vivo feasibility study. Surg Endosc. 2026 Jan;40(1):864-874. doi: 10.1007/s00464-025-12450-5. Epub 2025 Dec 12.
- Background: PubMed 40309063Qiao Y, Hu S, Shen W, Tang A, Zhang X, Zhang H, Min M, Liu Y. Novel endoscopic gastric purse-string suture device for weight management in a porcine model (with video). Endosc Int Open. 2025 Apr 15;13:a25399167. doi: 10.1055/a-2539-9167. eCollection 2025.
- Background: PubMed 40834899Hu S, Qiao Y, Zhang X, Min M, Liu Y. Transrectal endoscopic resection of intraperitoneal gastrointestinal stromal tumor facilitated by incidental segmental absence of intestinal musculature. Endoscopy. 2025 Dec;57(S 01):E945-E946. doi: 10.1055/a-2665-7697. Epub 2025 Aug 20. No abstract available.
- Individual participant dataSharing planned: No
Related trials for GIST - Gastrointestinal Stromal Tumor
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor
RecruitingObservational study
Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
Gastric Cancer, Gastric Neoplasm
RecruitingPhase 1
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Gastrointestinal Stromal Tumor (GIST), Gastrointestinal Stromal Cancer
RecruitingPhase 3
A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)
Gastrointestinal Stromal Neoplasms
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.
Yan Liu, M.D.,Ph.D. principal investigator
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Novel Two-Tooth Endoscopic Clip and Clip in people with GIST - Gastrointestinal Stromal Tumor, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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 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?
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 Min Min, M.D., Ph.D. (+86-010-66947473, minmin823@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Submucosal Dissection Efficiency (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07581977, which also lists 4 linked publications.
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 22 May 2026.