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NCT Number: NCT01696305

Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy

This study is a randomized, double-blind, active controlled phase 3 trial in the patients with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the patient with the past history of thyroid surgery).

An eligible patient will be randomized and allocated to either the test group (Hyalobarrier) or active-comparator group (Guardix-SG). He/she will undergo marshmallow esophagography in detecting esophageal dysmotility at 6 weeks after study intervention and will be followed for 12weeks.

During the study, both the patients and the observer for the primary and secondary efficacy evaluation will be masked.

Non-inferiority of the test device (Hyalobarrier) compared to the reference device (Guardix-SG) will be confirmed using the primary efficacy outcome,the percentage of normal esophageal transit.

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Key information

Conditions

Thyroid Disease Endocrine System Diseases Thyroid Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Konkuk University Medical Center, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female between 18 and 79 years of age
  • Patients diagnosed with thyroid disease who will undergo total thyroidectomy
  • Naive patients to thyroid surgery
  • Given written informed consent
  • Childbearing potential female patients who give the consent for contraception during the study

Exclusion criteria

  • Pregnant or breast-feeding female patients
  • Abnormal coagulation panel test
  • Clinically abnormal laboratory values
  • Inappropriate general health conditions
  • Past or current medication history for hyperthyroidism
  • Medication with aspirin (or anti-platelet) before surgery
  • Current medication with anticoagulants
  • Inoperable (thyroidectomy) concurrent diseases
  • Concurrent diseases/conditions which will be unable to evaluate the primary and secondary outcomes
  • Participating in other interventional clinical trial

Treatment and study plan

Hyalobarrier

Device

Guardix-SG

Device

Primary outcomes

  1. The percentage of normal esophageal transit in marshmallow esophagography

    Time frame: 6 Weeks after intervention

Secondary outcomes

  1. Adhesion severity using VAS

    Time frame: Baseline and 1, 6 and 12 weeks

  2. Swallow impairment

    Time frame: Baseline and 1, 6 and 12 weeks

  3. Voice impairment

    Time frame: Baseline and 1, 6 and 12 weeks

  4. voice behavior using Voice Range Profile (VRP) assessment

    Time frame: Baseline and 1, 6 and 12 weeks

  5. Injury of recurrent laryngeal nerve

    Time frame: Baseline and 1, 6 and 12 weeks

  6. Postoperative Sore Throat within 24hours after thyroidectomy

    Time frame: Pre- and Post (0, 24h)-opreation

  7. Adverse Events

    Time frame: during 12 weeks after investigational device use

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study title

Prospective, Randomized, Double Blind, Multicenter Study for Hyalobarrier ® to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG® After Thyroidectomy

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 1, 2012
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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