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Compensation: Varies

Number of Visits: 1

Duration: Immediate

50 Participants Needed

Bronchoscopy for Airway Stents
(SCOPE-IT Trial)

Overseen ByAxel Duval, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Cognitive impairment, Terminal illness, Tracheostomy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Bronchoscopy for Airway Stents?

Research shows that bronchoscopy is effective in placing airway stents, which help keep airways open in patients with blockages. A study found that stent insertion using bronchoscopy is generally well-tolerated and effective in managing airway obstructions, especially in advanced cancer cases.¹ ² ³ ⁴ ⁵

Is bronchoscopy generally safe for humans?

Bronchoscopy is generally considered safe when guidelines are followed, but it can cause anxiety and fear. Complications can include infections, especially with stents, and careful management by a medical team is important to avoid issues.⁴ ⁶ ⁷ ⁸ ⁹

How does bronchoscopy for airway stents differ from other treatments for airway obstruction?

Bronchoscopy for airway stents is unique because it allows for the placement of stents to keep airways open, using a flexible bronchoscope under conscious sedation, which can be done as a day-case procedure. This approach is particularly useful for quickly addressing severe airway obstructions and is often used for palliative care in cancer patients or as a temporary solution in non-cancerous conditions.¹⁰ ¹¹ ¹² ¹³ ¹⁴

What is the purpose of this trial?

Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting

Research Team

Udit Chaddha, MBBS

Principal Investigator

Icahn School of Medicine

Eligibility Criteria

This trial is for adults who've had a stent placed in their central airways due to medical conditions. Candidates must be able to give informed consent and not have tracheostomies or short-term stents for airway collapse. Those too ill for follow-up procedures are excluded.

Inclusion Criteria

I have had a stent placed in my central airway.

Exclusion Criteria

Lobar or segmental stents alone

I had a stent inserted for severe airway collapse, lasting 1-2 weeks.

I am unable to understand or sign the consent form due to cognitive or mental health issues.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo tracheobronchial stenting

Immediate

Surveillance

Surveillance bronchoscopy scheduled 4-6 weeks after stent insertion for the experimental group

4-6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for stent-related complications

3 months

Treatment Details

Interventions

Bronchoscopy

Trial Overview The study is testing if it's better to monitor patients with bronchoscopy after they get an airway stent, compared to no monitoring at all. It's a pilot study where participants are randomly chosen to either receive surveillance or not.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Surveillance GroupExperimental Treatment1 Intervention

Patients will be scheduled to undergo a surveillance bronchoscopy 4-6 weeks after the stent insertion.

Group II: No SurveillanceActive Control1 Intervention

Patients will only undergo bronchoscopies if warranted by clinical symptoms deemed to be secondary to stent-related complications.

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Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Findings from Research

In a 15-month study of 697 patients undergoing advanced diagnostic bronchoscopy, severe complications were rare, occurring in only 2.4% of patients, but they had serious consequences, including unplanned hospital visits and deaths.

Many complications occurred days or weeks after the procedure, highlighting the need for proactive monitoring to identify and manage these delayed adverse events effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thirty-Day Complications, Unplanned Hospital Encounters, and Mortality after Endosonography and/or Guided Bronchoscopy: A Prospective Study.Magnini, D., Sotgiu, G., Bello, G., et al.[2023]