Clinical trial NCT03937011: Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS
Official title: A Prospective, Multicenter, Multispecialty Evaluation of STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices in Robotic Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric - Sleeve Gastrectomy Staple Line Reinforcement
Gynecology - Vaginal Cuff Closure
Keywords: STRATAFIX SPIRAL PDS PLUS, ROBOTIC SUTURING,
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-03
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects ≥ 18 years who are undergoing elective/non-emergent gastric or gynecological procedures robotically

Brief summary: This single-arm, prospective, observational multicenter study will collect clinical data in a post-market setting across two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line reinforcement) and Hysterectomy (Vaginal cuff closure). Investigators will perform the procedure using SFX Spiral PDS Plus in compliance with their standard surgical approach and the IFU.


Eligibility criteria: Inclusion:

1. Elect to have a Robotic Bariatric Sleeve Gastrectomy or Robotic Total Hysterectomy where STRATAFIX™ Spiral PDS™ Plus device is used for staple line re-enforcement or vaginal cuff closure, respectively
2. Are willing and able to give consent and comply with all study-related evaluations and treatment scheduled
3. Subjects are ≥ 18 years of age

Exclusion:

1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits
2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
3. Enrolled in a concurrent clinical study (drug/device) that might affect current study primary or secondary endpoints
4. Allergic to poly (p-dioxanon), IRGACARE®\* MP (triclosan) or D\&C Violet No. 2 colorant
5. Pregnant or lactating female subjects as confirmed prior to the procedure
6. Subjects undergoing radical hysterectomy (Type B, C and D) according to Querleu \& Morrow classification or gastric sleeve revision surgery

Primary outcomes:
measure: Percentage of subjects with no bleeding or mild bleeding (defined as success) at the completion of the suturing at the organ layer (vaginal cuff closure or gastric staple line reinforcement using STRATAFIX™ Spiral PDS™ Plus).
timeFrame: Intra-op assessment (During Surgery; after suturing of the target tissue, Day of surgery)
Secondary outcomes:
measure: Qualitative Assessment of Suture Handling
timeFrame: Intra-op (at surgery, after suturing of the target tissue layer, Day of surgery)
measure: Time to Closure (in minutes/seconds)
timeFrame: Intra-op (during suturing of the target tissue, Day of surgery)
measure: Overall procedure time (first incision to skin closure)
timeFrame: Intra-op (during the surgery, Day of surgery)
measure: Length of stay in hours
timeFrame: Post-Operative up to 48 hrs
measure: Estimated intra-operative blood loss per institutional standard of care and incidence of subjects requiring blood transfusion
timeFrame: Intra-Op (during the surgery, Day of surgery)
measure: Intra-operative leak test in bariatric procedure as per institutional standard of care, if any
timeFrame: Intra-op (during Surgery; Day of surgery)
measure: Post-operative male/female dyspareunia related to sutures (total hysterectomy subjects)
timeFrame: 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days)
measure: Incisional site physical assessment:is suture palpable, suture line intact, or tender (all rated yes/no)
timeFrame: 14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days)
measure: Abnormal vaginal discharge (total hysterectomy subjects)
timeFrame: 14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days)
measure: C-SATS GEARS score
timeFrame: Intra-op (during the surgery, Day of surgery)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Albany
country: United States
facility: Albany Medical
state: New York
city: New York
country: United States
facility: Mt. Sinai
state: New York
city: New York
country: United States
facility: Lenox Hill hospital
state: New York
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf
city: Kiel
country: Germany
facility: Klinuk fur Allgemelne, Viszeral-ThoraxTransplantations- und Kinderchirurgie
city: Naples
country: Italy
facility: University of Naples
city: Pisa
country: Italy
facility: University Pisa
Study officials:
References: