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Development and application of temperature sensitive functional repair material for esophageal intestinal wound

Multi-center, randomized, controlled clinical trials evaluate the safety and efficacy of esophageal intestinal mucosal protective gel to promote wound healing and prevent bleeding

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053692
Enrollment
Unknown
Registered
2021-11-27
Start date
2020-12-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Mucosal and submucosal lesions of gastrointestinal tracts

Interventions

experimental group:use protective gel
Control group:Conventional treatment

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Gastroenterology patients with esophagus and intestinal endoscopic mucosal resection wounds >= 2 cm, requiring wound protection, and successfully completed endoscopic surgery; 2. Aged 18-80 years, gender is not limited; there is still a slight bleeding wound after the bleeding is stopped by clinical standard hemostasis procedures such as ligation, electrocoagulation, and slight compression; 3. The intended operation site is the primary operation; there is no active bleeding; there is no perforation of the esophagus wall and intestinal wall; and the informed consent is signed voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients with active infection or severe systemic disease; 2. Severe liver function or cardiopulmonary function damage; those with coagulation or bleeding dysfunction; 3. Patients who are pregnant or breastfeeding; those who have received glucocorticoid therapy within 6 weeks (excluding inhalers and eye drops); 4. Use of drugs that may affect the blood coagulation system within 1 week: such as platelet receptor antagonist abciximab, tirofiban, clopidogrel and other anticoagulant or procoagulant drugs; acid allergy patients; 5. Other patients who are not suitable for the operation of this product.

Design outcomes

Primary

MeasureTime frame
healing rate;

Secondary

MeasureTime frame
adverse event;ulcer area;

Countries

China

Contacts

Public ContactShen Zhe

Department of Gastroenterology, the First Affiliated Hospital, College of Medicine, Zhejiang University

sz8239@zju.edu.cn+86 13656713039

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026