Transoral endoscopic mediastinal surgery (TOEMS) for mediastinal lymph node biopsies - clinical phase I study.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00009886

Enrollment

Registered

2016-01-15

Start date

2010-10-23

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

D38.3

Interventions

Group 1: Single arm study without control group (phase I). In this study a scarless access for mediastinoscopy will be tested. This new approach for mediastinoscopy is based on transoral orifice endos

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Unclear mediastinal lymphadenopathy which was not resolved by prior bronchoscopy. 2. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Superior vena cava syndrome. 2. Palsy of recurrent nerve. 3. Previous operation of thyreoid gland.

Design outcomes

Primary

Measure	Time frame
Safety. All adverse events (AEs) and severe adverse advents (SAEs) will be monitored and recorded by the investigators. An AE is any unfavourable and unintended sign, symptom, or disease that occurs after starting treatment, regardless of whether the event is considered related or unrelated to the study intervention. The severity of each AE will be assessed using the following grading scale (CTCAE version 4.03: June 14, 2010): Grade 1:Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2:Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3:Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living Grade 4:Life-threatening consequences; urgent intervention indicated Grade 5:Death The investigators will inform the ethics committee about SAEs.	—

Measure

Time frame

Safety. All adverse events (AEs) and severe adverse advents (SAEs) will be monitored and recorded by the investigators. An AE is any unfavourable and unintended sign, symptom, or disease that occurs after starting treatment, regardless of whether the event is considered related or unrelated to the study intervention. The severity of each AE will be assessed using the following grading scale (CTCAE version 4.03: June 14, 2010): Grade 1:Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2:Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3:Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living Grade 4:Life-threatening consequences; urgent intervention indicated Grade 5:Death The investigators will inform the ethics committee about SAEs.

—

Secondary

Measure	Time frame
Accessibility of mediastinal lymph nodes by transoral surgery.	—

Countries

Germany

Contacts

Public ContactWolfram Klemm

Evangelische Lungenklinik Berlin

wolfram.klemm@pgdiakonie.de03094802102

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026