NCT00963716

Brief Summary

A new electrocautery bronchoscopy biopsy forceps is now commercially available and may prevent bleeding following biopsy. Only one study used this device wherein the authors concluded that the use of hot biopsy forceps for endobronchial biopsy does not appear to have a negative impact on the pathological samples, and that there was a statistically significant, albeit clinically insignificant reduction in bleeding score with hot biopsy forceps. Therefore, a randomized controlled study is required in which the hot and cold biopsies are performed to evaluate the tissue effect of the hot biopsy forceps on histopathological diagnosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
Last Updated

August 21, 2009

Status Verified

August 1, 2009

Enrollment Period

1.7 years

First QC Date

August 18, 2009

Last Update Submit

August 20, 2009

Conditions

Endobronchial GrowthLung Cancer

Keywords

endobronchial biopsybronchoscopyinterventional pulmonology

Outcome Measures

Primary Outcomes (1)

  • Quality of pathological specimen

    4 hours

Secondary Outcomes (1)

  • Severity of bleeding

    During procedure

Study Arms (2)

Hot biopsy

EXPERIMENTAL

Hot biopsy i.e. Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps

Device: Hot biopsy forceps

Cold biopsy

ACTIVE COMPARATOR

Cold biopsy i.e. Endobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps

Device: Cold biopsy forceps

Interventions

Hot biopsy forcepsDEVICE

Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps

Also known as: Hot biopsy
Hot biopsy
Cold biopsy forcepsDEVICE

Endobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps

Also known as: Cold biopsy
Cold biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing routine bronchoscopic biopsy for various indications
  • More than 18 years of age

You may not qualify if:

  • Bleeding diathesis
  • On pacemaker or implanted defibrillator
  • On anticoagulation therapy
  • Poor cardiopulmonary reserve
  • Marked hypoxemia
  • Uncooperative patient
  • Enrollment in the previous study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pulmonary Medicine, PGIMER, India

Chandigarh, Uttarakhand, 160012, India

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ashutosh N Aggarwal, MD, DM, FCCP

    PGIMER, Chandigrh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 21, 2009

Study Start

November 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 21, 2009

Record last verified: 2009-08

Locations

IN(1)