A clinical trial to evaluate the safety and efficacy of ‘MC-003’ compared to the mixture of normal saline and indigo carmine for patients in need of EMR or ESD to treat gastric neoplasm

A prospective, multicenter, triple-blind (investigator, evaluator, subject), randomized, superiority, pivotal clinical trial to evaluate the safety and efficacy of the submucosal injection solution ‘MC-003’ compared to the mixture of normal saline and Indigo Carmine for patients in needs of endoscopic mucosal resection or endoscopic submucosal dissection to treat gastric neoplasm

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0008837

Enrollment

Registered

2023-09-25

Start date

2021-02-15

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : • Trial group: EMR or ESD with MC-003 as a submucosal injection solution. • Control group: EMR or ESD with the mixture of normal saline and Indigo Carmine) as a submucosal injection s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. patients aged 20 to 80 years. 2. patients with a gastric adenoma or adenocarcinoma with a diameter of 5mm to 30 mm (absolute indication for EMR or ESD). 3. decide to participate in this clinical trial voluntarily and provide written informed consent. 4. willing to comply with the clinical trial protocol.

Exclusion criteria

Exclusion criteria: 1. 2 or more lesions requiring treatment 2. history of hypersensitivity to sodium alginate and Pectin substances 3. bleeding tendency 4. thrombotic disorders 5. unable to discontinue antiplatelet drugs and anticoagulants for at least 7 days 6. history of hypersensitivity to drugs used for sedation (e.g., Midazolam, Propofol, Isoflurane, fentanyl) 7. significant comorbidities such as severe liver, kidney, or cardiovascular disease 8. sepsis 9. uncontrolled diabetes mellitus 10. patients taking immune-suppressants including prednisolone or anti-cancer agents 11. patients with pacemakers 12. drug abuse or misuse, or alcohol- or drug-addicted 13. pregnant or lactating women 14. women who wish to become pregnant during the clinical trial (about 3 months) 15. currently participating in another study or have participated in another study within 90 days of the screening date 16. patients judged by the investigator as inappropriate for inclusion, either ethically or because it can affect clinical trial results (Specific reasons should be stated in the case record form) 17. Exclusion criteria for lesions ? lesion with ulcer ? advanced malignant neoplasm ? residual or recurrent lesion ? undifferentiated cancer ? lesion that had spread to the pyloric ring or the esophagogastric junction

Design outcomes

Primary

Measure	Time frame
Usefulness rate (N%)	—

Secondary

Measure	Time frame
Total evaluation grade (N%);The volume of the solution injected (ml/mm);Mucosal elevation shape (N%);Ease of mucosal resection (N%);Procedure-related complications rate (N%);Time required for mucosal resection (min)	—

Countries

Korea, Republic of

Contacts

Public ContactCHO JOOYOUNG

CHA Gangnam Medical Center CHA University

cjy6695@naver.com+82-2-3468-3000

Outcome results