Development of Novel Haemorrhoid Ligator for Internal Haemorrhoids

Development of Novel Haemorrhoid Ligator for the Removal of Internal Haemorrhoids

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250427012

Enrollment

140

Registered

2025-04-27

Start date

2020-05-15

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Internal Haemorrhoids Rubber Band Ligation Internal Haemorrhoids General Surgery

Interventions

Using our newly designed haemorrhoid ligator for the rubber band ligation treatment for internal haemorrhoids. This is the intervention group used for comparison.,Using the traditional haemorrhoid lig

Experimental Device,Active Comparator Device

New Haemorrhoid Ligator,Traditional Barron Ligator

Eligibility

Sex/Gender

All

Age

25 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who are diagnosed with grade II or III internal haemorrhoids. 2. Patients who are of sound mental status and are able to discharge informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with coagulopathy disorders, on anticoagulation therapy, or patients with thrombocytopaenia. 2. Patients with concurrent infection or inflammation in the anal region, including proctitis, perianal abscess, anal fistula, et cetera. 3. Patients with immunodeficiency disorders. 4. Pregnant patients. 5. Patients who wish to withdraw from the study.

Design outcomes

Primary

Measure	Time frame
Overall Quality Immediately post-intervention and 1 week post-intervention A weighted average of each outcome category, rated on a score out of 5 from questionnaires	—

Secondary

Measure	Time frame
Convenience Immediately post-intervention A score out of 5 on questionnaire,Equipment Quality Immediately post-intervention A score out of 5 on questionnaire,Equipment Efficacy Immediately post-intervention A score out of 5 on questionnaire,Periprocedural Complications Immediately post-intervention A score out of 5 on questionnaire,Adverse Effects Immediately post-intervention and at one-week follow-up A score out of 5 on questionnaire,Ease of maintenance Immediately post-intervention A score out of 5 on questionnaire	—

Measure

Time frame

Convenience Immediately post-intervention A score out of 5 on questionnaire,Equipment Quality Immediately post-intervention A score out of 5 on questionnaire,Equipment Efficacy Immediately post-intervention A score out of 5 on questionnaire,Periprocedural Complications Immediately post-intervention A score out of 5 on questionnaire,Adverse Effects Immediately post-intervention and at one-week follow-up A score out of 5 on questionnaire,Ease of maintenance Immediately post-intervention A score out of 5 on questionnaire

—

Countries

Thailand

Contacts

Public ContactChumpon Wilasrusmee

Department of Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University

chumpon.wil@mahidol.ac.th0985638435

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026