NCT04398823

A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

"Internal hemorrhoid" affects the quality of life due to hemorrhage and prolapse as a common and frequently-occurring disease. Endoscopic sclerosing agent injection has replaced traditional surgery and become the most commonly used treatment method in developed countries. At present, how to reduce the side effects of sclerosing agent and accurately determine the injection site and depth has become a difficult clinical problem. The research group creatively put forward the theory of foam sclerosing agent to treat internal hemorrhoids in the early stage. With the aid of transparent cap, the visibility of surgical field of vision can be improved. The mini probe ultrasound (MPS) is proposed to effectively evaluate the submucosal in

Conditions

• Grade/Stage I Hemorrhoids
• Prolapsed Grade II Internal Haemorrhoid
• Prolapsed Grade III Internal Haemorrhoid

Interventions

Type	Name	Description
DRUG	Sclerosing foam of Lauromacrogol	Participants in FS will receive enteroscopy with the sclerosing foam of lauromacrogol.
DRUG	Sclersing liqiud of Lauromacrogol	Participants in LS will receive enteroscopy with the sclerosing liquid of lauromacrogol.

Timeline

• Start date: 2020-05-15
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2020-05-21
• Last updated: 2020-05-21

Locations

1 site across 1 country: China