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Search / Trial NCT04169152

CAES for Internal Hemorrhoids and Rectal Prolapse

Launched by FAMING ZHANG · Nov 16, 2019

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Cap Assisted Endoscopic Sclerotherapy Internal Hemorrhoid Rectal Prolapse

ClinConnect Summary

This clinical trial is studying a new treatment called cap-assisted endoscopic sclerotherapy (CAES) for people suffering from internal hemorrhoids and rectal prolapse. These conditions can cause discomfort and other issues, and CAES is being explored as a less invasive option that could improve treatment outcomes. The goal of this study is to gather more information about how effective and safe CAES is over the long term.

To participate in this trial, individuals should have grade I to III internal hemorrhoids or rectal prolapse and be prepared for the procedure. However, those with certain conditions, such as severe hemorrhoids, anal issues, or uncontrolled high blood pressure, won't be eligible. If you join the study, you can expect to receive the CAES treatment under careful observation, with the aim of helping researchers understand its benefits and risks better. This research is important for potentially making this new therapy more widely available to patients in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Grade I-III internal hemorrhoids (with or without external hemorrhoids) or/and recal prolapse.
  • 2. Patients with bowel preparation.
  • Exclusion Criteria:
  • 1. History of anoscopic/endoscopic sclerotherapy.
  • 2. Acute thrombotic hemorrhoids or grade IV internal hemorrhoids.
  • 3. Anal stenosis, perianal and perirectal abscess, anal fissure, fistula, fecal incontinence and other severe complications (such as severe anal pain).
  • 4. Inflammatory bowel disease.
  • 5. Full-thickness rectal prolapse through the anus.
  • 6. Acute diarrhea in the past 24 hours.
  • 7. Hypertensive with uncontrolled blood pressure.
  • 8. Cerebrovascular accident.
  • 9. Blood coagulation dysfunction.
  • 10. Pregnant women.
  • 11. Mental disorders.
  • 12. Decompensated cirrhosis.

About Faming Zhang

Faming Zhang is a dedicated clinical trial sponsor focused on advancing medical research and innovative therapies. With a commitment to enhancing patient outcomes, Faming Zhang oversees the design, implementation, and management of clinical trials across various therapeutic areas. The organization emphasizes rigorous scientific methodologies and ethical standards, collaborating with healthcare professionals and research institutions to ensure the integrity and reliability of trial results. By fostering a culture of innovation and collaboration, Faming Zhang aims to contribute significantly to the development of effective treatments that address unmet medical needs.

Locations

Nanjing, Jiangsu, China

Patients applied

0 patients applied

Trial Officials

Faming Zhang, MD,PhD

Study Chair

The Second Hospital of Nanjing Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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