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The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions

NCT04063085 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2024-04-17

No results posted yet for this study

Summary

The aim of this study is to assess the safety and effectiveness of PROTAHERE Absorbable Adhesion Barrier to prevent pelvic postoperative adhesions.

Conditions

  • Tissue Adhesion
  • Gynecologic Surgery

Interventions

DEVICE

PROTAHERE Absorbable Adhesion Barrier

40 mg/ml (4%) cross-linked hyaluronan

DEVICE

Hyalobarrier Gel

Laparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan

OTHER

No treatment

No anti-adhesion agent applied

DEVICE

Seprafilm Adhesion Barrier

a hyaluronate carboxymethylcellulose-based bioresorbable membrane

DEVICE

Gynecare Interceed (TC7) Absorbable Adhesion Barrier

an oxidized regenerated cellulose absorbable membrane

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • SciVision Biotech Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-25
Primary Completion
2022-01-05
Completion
2023-10-12

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04063085 on ClinicalTrials.gov