Who is sponsoring NCT01107795?

NCT01107795 is sponsored by University of Alabama at Birmingham.

What drugs are being tested in NCT01107795?

Interventions in NCT01107795: Transoral Robotic Surgery.

What condition does NCT01107795 study?

NCT01107795 studies Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS).

Is NCT01107795 still recruiting?

NCT01107795 is currently terminated. Last updated 6 January 2020.

Are results published for NCT01107795?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-01-06 · How we verify

NCT01107795

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Prospective Study to Evaluate Outcomes From Transoral BOT Resection for OSAHS

Terminated Results posted Last updated 6 January 2020

What this trial tests

trial testing Transoral Robotic Surgery in Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) in 41 participants. Terminated before completion.

Timeline

4 March 2010

Primary endpoint
28 May 2019

26 July 2019

Quick facts

Lead sponsor	University of Alabama at Birmingham
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	41
Start date	4 March 2010
Primary completion	28 May 2019
Estimated completion	26 July 2019
Sites	1 location across United States

Drugs / interventions tested

Transoral Robotic Surgery

Conditions studied

Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) — all drugs for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) →

Sponsor

University of Alabama at Birmingham

Who can join

18 and older, any sex, with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS). Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Transoral BOT

Serious: 2/41 (5%)

Deaths: 0/41

Serious adverse events (2 terms)

Reaction	System	Transoral BOT
syncope	Nervous system disorders	—
laryngeal edema	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (3 terms — click to expand)

Reaction	System	Transoral BOT
pain	General disorders	—
postoperative hemorrhage	Injury, poisoning and procedural complications	—
aspiration	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: syncope, laryngeal edema.

Data from ClinicalTrials.gov NCT01107795 adverse events section.

Sponsor's own description

This is a prospective observational study that will collect outcome data for patients who choose to undergo transoral tongue base operations for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)as part of their standard of care treatment. This is a data collection study only and does not provide for evaluations or treatment of OSAHS.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

[Robotic Surgery - Who is The Boss?]
Schuler PJ. · · 2018 · cited 6× · PMID 29905359 · DOI 10.1055/s-0043-121791

Verify or expand the search:

Other trials of Transoral Robotic Surgery

Trials testing the same drug.

NCT05108870 — TheraT® Vectors (Vaccines) Combined With Chemotherapy to Treat HPV16 Head and Neck Cancers · Phase 1, PHASE2 · not yet recruiting
NCT04795817 — Treatment of Obstructive Sleep Apnea (OSA) With the da Vinci® SP™ Surgical System · completed
NCT03618134 — Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants · Phase 1, PHASE2 · terminated

Other University of Alabama at Birmingham trials

Trials by the same sponsor.

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NCT04768777 — Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis · NA · not yet recruiting
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01107795 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
Last refreshed: 6 January 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01107795.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing