Clinical trial · Interventional
Robotic Harvest of the Latissimus Dorsi (LD) Muscles
Pilot Study of Robotic-Assisted Harvest of the Latissimus Dorsi Muscles
NCT02274493CI-TRIAL-00037771completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn more about the safety and feasibility of using the Da Vinci Robotic Surgical system in procedures that harvest the latissimus dorsi muscle (a back muscle below your shoulder) for reconstructive procedures.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Complications | — | UNRESOLVED | — |
| Failure of Muscle Graft | — | UNRESOLVED | — |
| Other Reconstructive Surgery | — | UNRESOLVED | — |
| Surgical Procedure, Unspecified | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| da Vinci® Robotic Surgical System | Device | — | UNRESOLVED |
| LD muscle flap harvest procedure | Procedure | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Reconstructive surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic Harvest of the LD Muscles
- description
- Surgical harvesting of the Latissimus Dorsi (LD) Muscles using da Vinci® robotic surgical system in participants undergoing LD muscle flap harvest procedures in conjunction with breast, scalp, upper extremity and lower extremity reconstructive surgery procedures.
- interventionNames
- Device: da Vinci® Robotic Surgical System
- Procedure: LD muscle flap harvest procedure
- Procedure: Reconstructive surgery
- Behavioral: Questionnaires
Primary outcomes (2)
- measure
- Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability
- timeFrame
- Participants were followed for up to a total of 6 months post-operatively
- description
- Muscle flap viability was determined by measuring the blood flow into and out of the muscle flap with a hand held Doppler after muscle harvest was complete
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subject must be equal to or greater than 18 years of age. 2. The subject must be willing and able to provide informed consent. 3. The subject is willing and able to comply with the study protocol. 4. The subject is undergoing one of the following reconstructive procedures that requires latissimus dorsi muscle harvest: a. Post-mastectomy breast reconstruction procedure (either nipple or skin sparing) in which a female subject needs additional muscle coverage over an implant, but does not need additional skin (i.e., patient is a candidate for a pedicled latissimus dorsi muscle flap procedure); b. Scalp reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage; c. Upper extremity reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage; or, d. Lower extremity reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage. 5. The subject agrees to follow-up examinations out to 6 months post-treatment. Exclusion Criteria: 1. The subject has a BMI \> 35. 2. The subject has a history of significant bleeding disorders. 3. The subject is diabetic. 4. The subject is known or suspected to be pregnant or lactating. 5. The subject has a history of peripheral vascular disease. 6. The subject is a current smoker (has smoked within 4 weeks prior to surgery). 7. The subject has had prior back or axillary surgeries which could compromise the blood supply of the flap.
References
Publications (0)
Data not yet available
No reference posted for this study.