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Clinical study of pronase improving visibility and safety in colonoscopy

Clinical study of pronase improving visibility and safety in colonoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071702
Enrollment
Unknown
Registered
2023-05-23
Start date
2023-06-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

colonoscopy

Interventions

experimental group :pronase

Sponsors

The First Medical Center, Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who voluntarily participate and sign the informed consent form; 2. Male or female, aged 18-65 years (including 18 and 65 years); 3. Patients who determined to require and able to undergo colorectal screening, monitoring, and diagnosis of gastrointestinal symptoms, including: (1) Patients undergoing colorectal tumour screening, including those who have never undergone colonoscopy before or whose first colonoscopy was normal; (2) Patients undergoing tumour surveillance (including polyps), including those with a family history of colorectal cancer, those with suspected colon tumours but negative barium enema X-rays, those with colonic polyps, high risk for rectal cancer who are older than 40 years and have an immediate family member with rectal cancer; (3) Patients with inflammatory bowel disease (not in the active stage of severe inflammatory bowel disease); (4) Patients with unexplained diarrhoea or constipation require colonoscopy for diagnosis; 4. Subjects whose current health status is assessed by the investigator to be tolerant of colonoscopy(based on physical examination or past medical history).

Exclusion criteria

Exclusion criteria: 1. Progressive cancer that may lead to extensive colonic mucosal lesions; 2. Confirmed or suspected intestinal obstruction, intestinal perforation, toxic colitis or toxic megacolon, active inflammatory bowel disease (including severe ulcerative colitis), history of diverticulitis; 3. History of major gastrointestinal surgery (e.g., colostomy, colectomy, gastric bypass, gastric septal surgery); 4. History of perforation risk, bleeding risk, heart failure (NYHA class III or IV) or severe cardiovascular disease during colonoscopy; 5. Known need for microscopic treatment (e.g., mucosal resection); 6. Need for foreign body removal and decompression via colonoscopy; 7. Allergy to any component of the study drug; 8. Participation in other clinical studies within 3 months before signing the informed consent form; 9. Subjects should not be enrolled the patients who are in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Visual field clarity during colonoscopy;

Secondary

MeasureTime frame
The detection rate of intestinal lesions in colonoscopy;physicians' satisfaction in colonoscopy;The safety of using pronase during colonoscopy;

Countries

China

Contacts

Public ContactEnqiang Linghu

The First Medical Center, Chinese PLA General Hospital

zhangbo_pla301@163.com+86 10 6693 7485

Outcome results

None listed

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