Endoscopic Mucosal ResectionNCT07315893
Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System
A study testing Su2ura® GI system, Physical Examination and Vital Signs in people with Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection (ESD), run by Anchora Medical at 1 site in Israel.
Trial summary
The objective of this clinical study is to assess the safety of the Su2ura® GI system when used for endoscopic suturing and soft-tissue approximation in patients referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric neoplastic lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection (ESD)
- What is being tested?
- Su2ura® GI system, Physical Examination and Vital Signs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Aug 2025to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patient is able to provide informed consent .
- Body mass index (BMI) 20-40 kg/m2
- Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of a gastric neoplastic lesion
- Candidate for endoscopic defect closure based on the operating's endoscopist assessment.
Who cannot join
- Patient with severe comorbidities likely to limit survival to less than 2 years.
- Patients with INR>1.5
- Patients with PLT< 150
- Patient with known collagen or connective tissue disorders (e.g. scleroderma, marfan syndrome) .
- Pregnant women or those intending to become pregnant during the study period
- Patient with ascites on physical examination or CT scan.
Show all 16Show fewer
- Patient with varices.
- Patient on peritoneal dialysis.
- Patient with wound-healing disorders.
- Patient with significant coagulation disorders or those requiring anti thrombotic or anticoagulation treatment other than aspirin .
- Patient with autoimmune disorder requiring more than 10 mg of corticosteroid daily .
- Patients in need of immunomodulatory therapy.
- Immunocompromised patients (e.g., HIV/AIDS, organ transplant, chemo- or radiation therapy 6 months prior to recruitment).
- Patient in need of concomitant surgical procedures other than those permitted in the protocol.
- Non-compliance with the study protocol.
- Patient requests to exist the study. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Tel-Aviv Sourasky Medical Center, Ichilov
Tel Aviv
Iddo Bar-Yishay, MD, +972-51-5617202, iddob@tlvmc.gov.il
About this study
The objective of this clinical study is to assess the safety of the Su2ura® GI system when used for endoscopic suturing and soft-tissue approximation in patients referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric neoplastic lesions.
The main questions it aims to answer are:
Read more
- Percentage of patients with incomplete closure.
- Percentage of patients bleeding at closure site within 28 days from procedure.
- Percentage of patients with infection at closure site within 28 days from procedure.
- Percentage of patients with leakage within 72 hours from procedure.
- Serious Adverse Device Effects (SADE) within 28 days from procedure.
- Overall rates of Adverse Device Effect within 28 days from procedure.
Study includes 6 visits: Screening, Baseline/Surgery, Discharge and 4 weeks, 3 months and 6 months post-surgery. The actual point of enrollment for each subject is considered the day of surgery. Total study duration is up to 6.5 months.
The patient will be admitted to the medical center on the day of the procedure or one day prior for preoperative preparation. Following tissue resection using one of the methods (ESD or EMR), suturing will be performed using the Su2ura® GI system.
Postoperatively, the patient will be transferred to the recovery area and then to the surgical ward for standard monitoring, with an expected one-night postoperative stay and discharge the following day.
Study follow-up visits will take place 4 weeks, 3 and 6 months post surgery.
Read the detailed description
This study will be performed in accordance with the design and specific provisions of this protocol, in accordance with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP), Title 21 of the Code of Federal Regulations (21 CFR), part 812 (Investigational Device Exemptions), and the applicable regulatory requirements.
The study will be a prospective, single-center, open study, to evaluate the efficacy and safety of the Su2ura® GI System.
The study will be performed at the Tel Aviv Sourasky Medical Center, Israel. Up to 25 patients will be recruited to the study.
Following resection of the lesion using either endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), the procedure involves endoscopic insertion of the Su2ura® GI system through the gastroscope working channel, followed by tissue grasping and approximation using sequential deployment of T-Tag Anchors in a predefined suturing pattern. Full-thickness anchors are placed in a controlled manner to achieve safe and effective tissue approximation, after which the suture is secured using the Su2ura® Knot device.
Postoperatively, the patient will be transferred to the recovery area and then to the surgical ward for standard monitoring, with an expected one-night postoperative stay and discharge the following day.
- Being tested
- Su2ura® GI system, Physical Examination, Vital Signs, Blood Test-Hematology, Blood Test-Biochemistry
- Keywords
- endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), a gastric neoplastic lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Su2ura® GI systemDevice
The Su2ura® GI handle is used to control tissue grasping, anchor deployment, and suture placement, enabling controlled full-thickness tissue approximation through sequential deployment of T-Tag Anchors in a predefined suturing pattern.
Physical ExaminationDiagnostic test
The patient will undergo a standard physical examination by an authorized physician. The physician's evaluation will include diagnosis and documentation of any significant clinical abnormalities or diseases.
Vital SignsDiagnostic test
Vital signs include blood pressure, pulse, temperature, body weight and height, BMI.
Blood Test-HematologyDiagnostic test
All subjects will undergo Hematology blood tests. Blood Hematology and Biochemistry will include standard of care measurements. 5 ml of blood (equals to 1 spoon) will be taken for each test.
Blood Test-BiochemistryDiagnostic test
All subjects will undergo Biochemistry blood tests. Blood Hematology and Biochemistry will include standard of care measurements. 5 ml of blood (equals to 1 spoon) will be taken for each test.
Urine Pregnancy TestDiagnostic test
Women with child-bearing potential will undergo a urine pregnancy test during the screening visit.
GastroscopyDiagnostic test
During visit 4 (Day 28 ± 2 days after procedure) a gastroscopy examination will be performed, to negate local recurrence. The examination will be performed as accepted, with a gastroscope with an NBI/BLI optical filter. Biopsies will be sampled as needed, at a gastroenterologist's discretion.
Health-related quality of life (HR-QoL)Diagnostic test
A questionnaire assessing patient-reported satisfaction and function.
Visual Analogue Scale (VAS)Diagnostic test
A validated, subjective measure measuring acute and chronic pain.
| Study group | Role | What they receive |
|---|---|---|
| Su2ura® GI System-study device group | Experimental | All participants will undergo endoscopic suturing using a Su2ura® GI System following the ESD or EMR procedure. Receives: Device: Su2ura® GI system; Diagnostic Test: Physical Examination; Diagnostic Test: Vital Signs; Diagnostic Test: Blood Test-Hematology; Diagnostic Test: Blood Test-Biochemistry; Diagnostic Test: Urine Pregnancy Test; Diagnostic Test: Gastroscopy; Diagnostic Test: Health-related quality of life (HR-QoL); Diagnostic Test: Visual Analogue Scale (VAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with incomplete closure.
Percentage of patients with incomplete closure.
Measured: Up to 28 days
Patients bleeding at closure site.
Percentage of patients bleeding at closure site within 28 days from procedure.
Measured: Up to 28 days
Patients with infection at closure site.
Percentage of patients with infection at closure site within 28 days from procedure.
Measured: Up to 28 days
Patients with leakage.
Percentage of patients with leakage within 72 hours from procedure.
Measured: Up to 72 hours
Serious Adverse Device Effects (SADE)
Serious Adverse Device Effects (SADE) within 28 days from procedure.
Measured: Up to 28 days
Overall rates of Adverse Device Effect
Overall rates of Adverse Device Effect within 28 days from procedure.
Measured: Up to 28 days
Secondary outcomes (4)
Overall rates of Serious Adverse Events
Overall rates of Serious Adverse Events will be recorded up to 180 days following the procedure.
Measured: Up to 180 days
Serious Adverse Device Effects
Serious Adverse Device Effects (SADE) will be evaluated endoscopically at 2-14 and 90 days.
Measured: Up to 90 days
Evidence of a Leak
Clinical, radiologic or endoscopic evidence of a Leak within 30 days
Measured: Up to 30 days
Patient Quality of Life
Patient quality of life will be assessed by validated Health-Related Quality of Life Scale questionnaire.
The questionnaire includes several measures of perceived health status. The primary overall outcome is the Unhealthy Days Score, calculated as the sum of the number of days of poor physical health and poor mental health during the past 30 days. The score ranges from 0 to 30 days, with higher scores indicating worse health status and lower scores indicating better health status.
Measured: Up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start18 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Mucosal ResectionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo endoscopic suturing using a Su2ura® GI System following the ESD or EMR procedure.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anchora Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315893
- Sponsor's protocol ID
- ANC-201
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System
- ClinicalTrials.gov ID
- NCT07315893
- Acronym / sponsor ID
- ANC-201
- Keywords
- endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), a gastric neoplastic lesion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Anchora MedicalUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 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.
The objective of this clinical study is to assess the safety of the Su2ura® GI system when used for endoscopic suturing and soft-tissue approximation in patients referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric neoplastic lesions.
The main questions it aims to answer are:
- Percentage of patients with incomplete closure.
- Percentage of patients bleeding at closure site within 28 days from procedure.
- Percentage of patients with infection at closure site within 28 days from procedure.
- Percentage of patients with leakage within 72 hours from procedure.
- Serious Adverse Device Effects (SADE) within 28 days from procedure.
- Overall rates of Adverse Device Effect within 28 days from procedure.
Study includes 6 visits: Screening, Baseline/Surgery, Discharge and 4 weeks, 3 months and 6 months post-surgery. The actual point of enrollment for each subject is considered the day of surgery. Total study duration is up to 6.5 months.
The patient will be admitted to the medical center on the day of the procedure or one day prior for preoperative preparation. Following tissue resection using one of the methods (ESD or EMR), suturing will be performed using the Su2ura® GI system.
Postoperatively, the patient will be transferred to the recovery area and then to the surgical ward for standard monitoring, with an expected one-night postoperative stay and discharge the following day.
Study follow-up visits will take place 4 weeks, 3 and 6 months post surgery.
Detailed description
This study will be performed in accordance with the design and specific provisions of this protocol, in accordance with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP), Title 21 of the Code of Federal Regulations (21 CFR), part 812 (Investigational Device Exemptions), and the applicable regulatory requirements.
The study will be a prospective, single-center, open study, to evaluate the efficacy and safety of the Su2ura® GI System.
The study will be performed at the Tel Aviv Sourasky Medical Center, Israel. Up to 25 patients will be recruited to the study.
Following resection of the lesion using either endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), the procedure involves endoscopic insertion of the Su2ura® GI system through the gastroscope working channel, followed by tissue grasping and approximation using sequential deployment of T-Tag Anchors in a predefined suturing pattern. Full-thickness anchors are placed in a controlled manner to achieve safe and effective tissue approximation, after which the suture is secured using the Su2ura® Knot device.
Postoperatively, the patient will be transferred to the recovery area and then to the surgical ward for standard monitoring, with an expected one-night postoperative stay and discharge the following day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo endoscopic suturing using a Su2ura® GI System following the ESD or EMR procedure.
| Arm | Type | Receives |
|---|---|---|
| Su2ura® GI System-study device group | Experimental | Device: Su2ura® GI system, Diagnostic Test: Physical Examination, Diagnostic Test: Vital Signs, Diagnostic Test: Blood Test-Hematology, Diagnostic Test: Blood Test-Biochemistry, Diagnostic Test: Urine Pregnancy Test, Diagnostic Test: Gastroscopy, Diagnostic Test: Health-related quality of life (HR-QoL), Diagnostic Test: Visual Analogue Scale (VAS)All participants will undergo endoscopic suturing using a Su2ura® GI System following the ESD or EMR procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Patient is able to provide informed consent .
- Body mass index (BMI) 20-40 kg/m2
- Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of a gastric neoplastic lesion
- Candidate for endoscopic defect closure based on the operating's endoscopist assessment.
Key exclusion criteria (16 listed)
- Patient with severe comorbidities likely to limit survival to less than 2 years.
- Patients with INR>1.5
- Patients with PLT< 150
- Patient with known collagen or connective tissue disorders (e.g. scleroderma, marfan syndrome) .
- Pregnant women or those intending to become pregnant during the study period
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 |
|---|---|---|
| Su2ura® GI systemThe Su2ura® GI handle is used to control tissue grasping, anchor deployment, and suture placement, enabling controlled full-thickness tissue approximation through sequential deployment of T-Tag Anchors in a predefined suturing pattern. | Device | Su2ura® GI System-study device group |
| Physical ExaminationThe patient will undergo a standard physical examination by an authorized physician. The physician's evaluation will include diagnosis and documentation of any significant clinical abnormalities or diseases. | Diagnostic test | Su2ura® GI System-study device group |
| Vital SignsVital signs include blood pressure, pulse, temperature, body weight and height, BMI. | Diagnostic test | Su2ura® GI System-study device group |
| Blood Test-HematologyAll subjects will undergo Hematology blood tests. Blood Hematology and Biochemistry will include standard of care measurements. 5 ml of blood (equals to 1 spoon) will be taken for each test. | Diagnostic test | Su2ura® GI System-study device group |
| Blood Test-BiochemistryAll subjects will undergo Biochemistry blood tests. Blood Hematology and Biochemistry will include standard of care measurements. 5 ml of blood (equals to 1 spoon) will be taken for each test. | Diagnostic test | Su2ura® GI System-study device group |
| Urine Pregnancy TestWomen with child-bearing potential will undergo a urine pregnancy test during the screening visit. | Diagnostic test | Su2ura® GI System-study device group |
| GastroscopyDuring visit 4 (Day 28 ± 2 days after procedure) a gastroscopy examination will be performed, to negate local recurrence. The examination will be performed as accepted, with a gastroscope with an NBI/BLI optical filter. Biopsies will be sampled as needed, at a gastroenterologist's discretion. | Diagnostic test | Su2ura® GI System-study device group |
| Health-related quality of life (HR-QoL)A questionnaire assessing patient-reported satisfaction and function. | Diagnostic test | Su2ura® GI System-study device group |
| Visual Analogue Scale (VAS)A validated, subjective measure measuring acute and chronic pain. | Diagnostic test | Su2ura® GI System-study device group |
Primary outcome
Patients with incomplete closure.
Time frame: Up to 28 days
Percentage of patients with incomplete closure.
Patients bleeding at closure site.
Time frame: Up to 28 days
Percentage of patients bleeding at closure site within 28 days from procedure.
Patients with infection at closure site.
Time frame: Up to 28 days
Percentage of patients with infection at closure site within 28 days from procedure.
Patients with leakage.
Time frame: Up to 72 hours
Percentage of patients with leakage within 72 hours from procedure.
Serious Adverse Device Effects (SADE)
Time frame: Up to 28 days
Serious Adverse Device Effects (SADE) within 28 days from procedure.
Overall rates of Adverse Device Effect
Time frame: Up to 28 days
Overall rates of Adverse Device Effect within 28 days from procedure.
4 secondary outcomes
Overall rates of Serious Adverse Events
Time frame: Up to 180 days
Serious Adverse Device Effects
Time frame: Up to 90 days
Evidence of a Leak
Time frame: Up to 30 days
Patient Quality of Life
Time frame: Up to 180 days
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 7 Jan 2026.
Related trials for Endoscopic Mucosal Resection
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Enrolling by invitation
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
Colon Polyp, Colon Adenoma
Not yet recruitingObservational study
Clinical Outcomes After EMR or ESD of Colorectal Neoplasms - A Multicenter Registry
Colorectal Cancer, Colorectal Neoplasms
Active, not recruiting
Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading Lesions.
Neoplasms, Colorectal
Recruiting
Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps
Colorectal Cancer, Polyp of Colon
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Su2ura® GI system, Physical Examination and Vital Signs in people with Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection (ESD), run by Anchora Medical at 1 site in Israel.
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 16 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 7 Jan 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 Israel. 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 Nadya Lisovoder, MD (+972-52-4753435, nadyal@galilee-cbr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with incomplete closure. (time frame: Up to 28 days). The study lists 6 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 7 Jan 2026.